510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944115Substantially Equivalent

Heparin Assay Cartridges and Controls

Medtronic Hemotec, Inc., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944115 is the FDA 510(k) clearance record for HEPARIN ASSAY CARTRIDGES AND CONTROLS, a class II device, cleared for Medtronic Hemotec, Inc. on under FDA product code GFT (Protamine Sulphate). FDA records list 5 510(k) clearances for Medtronic Hemotec, Inc., from to . As of , FDA records show no recalls naming K944115.

Clearance record

Decision date
Received
(213 days to decision)
Product code
GFT Protamine Sulphate
Regulation
21 CFR 864.7525
Device class
Class II
Review panel
Hematology
Applicant
Medtronic Hemotec, Inc. 7103 S. Revere Pkwy., Englewood CO
510(k) summary
Summary
Third party review
No

Clearances, product code GFT

Trailing 12 months

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

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