510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060651Substantially Equivalent

Proxis System, Model Eps101

Abbott Medical, Maple Grove MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060651 is the FDA 510(k) clearance record for PROXIS SYSTEM, MODEL EPS101, a class II device, cleared for St Jude Medical on under FDA product code NFA (Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K060651.

Clearance record

Decision date
Received
(184 days to decision)
Product code
NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
St Jude Medical 6550 Wedgwood Rd. N., Maple Grove MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NFA

Trailing 12 months

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

FDA records show no clearances under product code NFA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NFA, 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