Exhibit A

Case 2:15-md-02641-DGC Document 850-1 Filed 02/18/16 Page 1 of 3
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration

10903 New Hampshire Avenue

Document Control Center - WO66-G609

Silver Spring, MD 20993-0002

Bard Peripheral Vascular, Inc.

Ms. Joni Creal

Regulatory Affairs Program Manager

1625 West 3rd Street

Tempe, Arizona 85281

Re: K152136

Trade/Device Name: Recovery Cone® Removal System

Regulation Number: 21 CFR 870.5150

Regulation Name: Embolectomy Catheter

Regulatory Class: Class II 

Product Code: MMX

Dated: December 29, 2015

Received: January 05, 2016

Dear Ms. Creal:

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 devicerelated 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.

EXHIBIT A

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Case 2:15-md-02641-DGC Document 850-1 Filed 02/18/16 Page 2 of 3
Page 2 - Ms. Joni Creal

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,

Bram D. Zuckerman, M.D.

Director

Division of Cardiovascular Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

EXHIBIT A

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