510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K014223Substantially Equivalent

Modification to Guardwire Plus Temporary Occlusion & Aspiration System

Medtronic Percusurge, Inc., Sunnyvale CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K014223 is the FDA 510(k) clearance record for MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM, a class II device, cleared for Medtronic Percusurge, Inc. on under FDA product code NFA (Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection). FDA records list 2 510(k) clearances for Medtronic Percusurge, Inc., from to . As of , FDA records show no recalls naming K014223.

Clearance record

Decision date
Received
(30 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
Medtronic Percusurge, Inc. 540 Oakmead Pkwy., Sunnyvale CA
510(k) summary
Statement
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