MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing right, with flowing lines beneath them. The image is in black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 21, 2014 Boston Scientific Corporation Ms. Melanie Raska Director, Regulatory Affairs One Scimed Place Maple Grove, MN 55311 Re: K141521 > Trade/Device Name: Mustang PTA Balloon Dilatation Catheter Charger PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: July 28, 2014 Received: July 29, 2014 Dear Ms. Raska, We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device {1}------------------------------------------------ related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, ## Kenneth J. Cavanaugh -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Statement (if known) Device Name Mustang ™ PTA Balloon Dilatation Catheters The Mustang Balloon Dilatation Catheter is indicated for Indications for Use Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Mustang Balloon Dilatation Catheter is also indicated for post- K141521 510(k) Number dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart C) יי יי (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Boston Scientific Corporation Rtgo ctmgv'P qvkkecvkqp''ó''Dwpf rgf 'Ur gelcn'732 *m+''' O wrcpi ""cpf "Ej cti gt "RVC "Dcmqp"F kcvcvkqp"Ecy gggt"" " {3}------------------------------------------------ ## Indications for Use Statement | 510(k) Number<br>(if known) | K141521 | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Charger TM PTA Balloon Dilatation Catheters | | Indications for<br>Use | The Charger Balloon Dilatation Catheter is indicated for<br>Percutaneous Transluminal Angioplasty (PTA) in the peripheral<br>vasculature, including iliac, femoral, popliteal, tibial, peroneal,<br>subclavian, and renal arteries and for the treatment of obstructive<br>lesions of native or synthetic arteriovenous dialysis fistulae.<br><br>The Charger Balloon Dilatation Catheter is also indicated for post-<br>dilatation of balloon expandable and self-expanding stents in the<br>peripheral vasculature. | Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart C) יי (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) ## Concurrence of CDRH, Office of Device Evaluation (ODE) Boston Scientific Corporation Rtgo ctmgv'P qvkhlecvkqp"ó"Dwpf rgf "Ur gelcri'732*m+"" O wacpi ""cpf "Ej cti gt"TRVC "Dcmqqp"F kcxcvkqp"Ecvj gygt"" " יי