510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K931464Substantially Equivalent

Baxter Coronary Angioscope Inflation Device

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

K931464 is the FDA 510(k) clearance record for BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE, a class II device, cleared for Baxter Healthcare Corp on under FDA product code LYK (Angioscope). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K931464.

Clearance record

Decision date
Received
(208 days to decision)
Product code
LYK Angioscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Baxter Healthcare Corp 17221 Red Hill Ave., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code LYK

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