510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801637Substantially Equivalent

Fluoro-Mark Radiopaque Anatomical Mkr.

C.R. Bard Inc, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801637 is the FDA 510(k) clearance record for FLUORO-MARK RADIOPAQUE ANATOMICAL MKR., a class II device, cleared for C.R. Bard, Inc. on under FDA product code KPK (Marker, Ostia, Aorto-Saphenous Vein). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K801637.

Clearance record

Decision date
Received
(41 days to decision)
Product code
KPK Marker, Ostia, Aorto-Saphenous Vein
Regulation
21 CFR 878.4650
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
C.R. Bard, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KPK

Trailing 12 months

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

FDA records show no clearances under product code KPK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPK, 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