510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001915Substantially Equivalent

Graft Marker Ring

T. Korossurgical Instruments Corp., Moorepark CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001915 is the FDA 510(k) clearance record for GRAFT MARKER RING, a class II device, cleared for T. Korossurgical Instruments Corp. on under FDA product code MAB (Marker, Cardiopulmonary Bypass (Vein Marker)). FDA records list 27 510(k) clearances for T. Korossurgical Instruments Corp., from to . As of , FDA records show no recalls naming K001915.

Clearance record

Decision date
Received
(308 days to decision)
Product code
MAB Marker, Cardiopulmonary Bypass (Vein Marker)
Regulation
21 CFR 870.3450
Device class
Class II
Review panel
Cardiovascular
Applicant
T. Korossurgical Instruments Corp. 610 Flinn Ave., Moorepark CA
510(k) summary
Statement
Third party review
No

Clearances, product code MAB

Trailing 12 months

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

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