510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K951413Substantially Equivalent

Fogarty-Hydragrip Surgical Clamps

Baxter Healthcare Corporation, Mcgaw Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951413 is the FDA 510(k) clearance record for FOGARTY-HYDRAGRIP SURGICAL CLAMPS, a class II device, cleared for Baxter Healthcare Corp on under FDA product code DXC (Clamp, Vascular). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K951413.

Clearance record

Decision date
Received
(143 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Baxter Healthcare Corp 1500 Waukegan Rd., Mcgaw Park IL
510(k) summary
Summary
Third party review
No

Clearances, product code DXC

Trailing 12 months
5 clearances under product code DXC in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXC, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20261
July 20261
August 20260
September 20260
October 20260
November 20260