510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003446Substantially Equivalent

Symmetry Aortic Clip System

St. Jude Medical Cardiovascular Group, Inc., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003446 is the FDA 510(k) clearance record for SYMMETRY AORTIC CLIP SYSTEM, a class II device, cleared for St. Jude Medical Cardiovascular Group, Inc. on under FDA product code NCA (Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)). FDA records list one 510(k) clearance for St. Jude Medical Cardiovascular Group, Inc. As of , FDA records show no recalls naming K003446.

Clearance record

Decision date
Received
(196 days to decision)
Product code
NCA Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
St. Jude Medical Cardiovascular Group, Inc. 12300 Twinbrook Pkwy., Suite 625, Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code NCA

Trailing 12 months

FDA records hold no clearances under product code NCA in the trailing twelve months.

FDA records show no clearances under product code NCA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NCA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260