Table 1 Model of STRIDESMOOTH (Stride) and STRIDESMOOTH+ Microcatheter

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2 AMM-Q269 Ver.7 Page 2 of 5 Table 1 Model of STRIDESMOOTH (Stride) and STRIDESMOOTH+ Microcatheter Product name STRIDESMOOTH (Stride) Model No. STD105-22S STD125-22S STD125-22A STD130-22S STD150-22S STD105-26S STD125-26S STD150-26S Description STRIDESMOOTH (Stride) Microcatheter, 2.2 Fr, Straight, 105cm STRIDESMOOTH (Stride) Microcatheter, 2.2 Fr, Straight, 125cm STRIDESMOOTH (Stride) Microcatheter, 2.2 Fr, Angled, 125cm STRIDESMOOTH (Stride) Microcatheter, 2.2 Fr, Straight, 130cm STRIDESMOOTH (Stride) Microcatheter, 2.2 Fr, Straight, 150cm STRIDESMOOTH (Stride) Microcatheter, 2.6 Fr, Straight, 105cm STRIDESMOOTH (Stride) Microcatheter, 2.6 Fr, Straight, 125cm STRIDESMOOTH (Stride) Microcatheter, 2.6 Fr, Straight, 150cm Product name STRIDESMOOTH+ Model No. STP105-20S STP115-20S STP125-20S STP125-20A STP135-20S STP150-20S Description STRIDESMOOTH+ Microcatheter, 2.0 Fr, Straight, 105cm STRIDESMOOTH+ Microcatheter, 2.0 Fr, Straight, 115cm STRIDESMOOTH+ Microcatheter, 2.0 Fr, Straight, 125cm STRIDESMOOTH+ Microcatheter, 2.0 Fr, Angled, 125cm STRIDESMOOTH+ Microcatheter, 2.0 Fr, Straight, 135cm STRIDESMOOTH+ Microcatheter, 2.0 Fr, Straight, 150cm

3 AMM-Q269 Ver.7 Page 3 of 5 1. QA- RELATED STANDARDS EN ISO 13485:2012 AC:2012 ISO 13485:2003 Cor1:2009 EC Directive 93/42/EEC L Amd 1: 1998 Amd 2: 2000 Amd 3: 2002 Amd 4: 2003 Amd 5: PRODUCT- RELATED STANDARDS Table 2 Applied harmonized standards Medical devices Quality management systems Requirements for regulatory purposes Medical Devices Directive (2007) EN 556-1:2001 AC:2006 EN 556-2: 2003 ISO 594-2:1998 EN ISO : 2012 ISO : 2012 EN 1041:2008 EN 1707:1996 EN ISO :2009 ISO :1995 Amd 1:1999 Amd 2:2004 EN ISO :1997 C1:2002 ISO :1996 Cor 1:2002 EN ISO :2009 AC:2010 ISO :2009 Cor1:2010 EN ISO : 2006 ISO : 2006 EN ISO :2009 ISO :2002 Amd 1:2006 EN ISO :2009 ISO :2009 Sterilization of medical devices Requirements for medical devices to be designated "STERILE" Part 1: Requirements for terminally sterilized medical devices Sterilization of medical devices Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other Part 2: Lock fittings Medical devices-symbols to be used with medical device labels, labeling and information to be supplied Part1: General requirements Information supplied by the manufacturer with medical devices Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other Lock fittings Sterile, single-use intravascular catheters Part1: General requirement Sterile, single-use intravascular catheters Part2: Angiographic catheter Part 1: Evaluation and testing Biological evaluation of medical devices- Part 2: Animal welfare requirements Part 4: Selection of tests for interactions with blood Part 5: Tests for in vitro cytotoxicity

4 AMM-Q269 Ver.7 Page 4 of 5 EN ISO :2008 AC:2009 ISO :2008 Cor1:2009 EN ISO :2010 ISO :2010 EN ISO :2009 ISO :2006 EN ISO :2012 ISO :2012 EN ISO :2007 ISO :2007 EN ISO : 2006 ISO : 2006 EN ISO : 2009 ISO : 2006 EN ISO :2009 ISO :2006 EN ISO :2006: ISO :2006 EN ISO :2006 AC:2009 ISO :2006 Cor1:2007 EN ISO :2009 ISO :2009 EN ISO 14155: 2011 AC:2011 ISO 14155: 2011 Cor 1:2011 EN ISO 14161: 2009 ISO 14161: 2009 EN ISO :1999 ISO :1999 EN ISO : 2000 ISO : 2000 EN ISO :2005 ISO :2005 EN ISO : 2003 ISO : 2003 EN ISO : 2003 AC:2006 ISO : 2003 Cor 1: 2004 EN ISO 14971:2012 ISO 14971:2007 EN :1993 AC:1996 A1:1997 ISO 594-1:1986 Part 7: Ethylene oxide sterilization residuals Part 10: Tests for irritation and delayed-type hypersensitivity Part 11: Tests for systemic toxicity Part 12: Sample preparation and reference materials Sterilization of health care products - Ethylene oxide - Part 1:Requirements for development, validation and routine control of a sterilization process for medical devices Part 1: General requirements Part 2: Biological indicators for ethylene oxide sterilization processes Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems First edition Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes First edition Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products Sterilization of medical devices Microbiological methods Part 2: Determination of a population of microorganisms on products Clinical investigation of medical devices for human subjects Good clinical practice Guidance for the selection, use and interpretation of results First edition Part 1: Classifications of air cleanliness Part 2: Specifications for testing and monitoring to prove continued compliance with ISO First edition Part 3: Test menthods Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods Cleanrooms and associated controlled environments -- Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data Medical device Application of risk management to medical devices Conical fittings with a 6% (Luer) taper for syringes, needles and certain other Part 1: General requirements

5 AMM-Q269 Ver.7 Page 5 of 5 3. PRODUCT- RELATED GUIDANCE MEDDEV : 2009 MEDDEV :2013 MEDDEV : 2012 EVALUATION OF CLINICAL DATA: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM POST MARKET CLINICAL FOLLOW-UP STUDIES