510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K902143Substantially Equivalent

Fogarty Vessel Calibrator

Baxter Healthcare Corporation, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902143 is the FDA 510(k) clearance record for FOGARTY VESSEL CALIBRATOR, a class II device, cleared for Baxter Healthcare Corp on under FDA product code DWP (Dilator, Vessel, Surgical). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K902143.

Clearance record

Decision date
Received
(154 days to decision)
Product code
DWP Dilator, Vessel, Surgical
Regulation
21 CFR 870.4475
Device class
Class II
Review panel
Cardiovascular
Applicant
Baxter Healthcare Corp P O Box 11150, Santa Ana CA
Third party review
No

Clearances, product code DWP

Trailing 12 months

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

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