510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K965137Substantially Equivalent

Fogarty Valvulotome Model 700091

Baxter Edwards, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965137 is the FDA 510(k) clearance record for FOGARTY VALVULOTOME MODEL 700091, a class II device, cleared for Baxter Edwards on under FDA product code MGZ (Valvulotome). FDA records list 11 510(k) clearances for Baxter Edwards, from to . As of , FDA records show no recalls naming K965137.

Clearance record

Decision date
Received
(163 days to decision)
Product code
MGZ Valvulotome
Regulation
21 CFR 870.4885
Device class
Class II
Review panel
Cardiovascular
Applicant
Baxter Edwards 17221 Red Hill Ave., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code MGZ

Trailing 12 months
1 clearance under product code MGZ in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MGZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260