510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001245Substantially Equivalent

3T L. V. Control Valve

3T Medical Systems Inc., Troy MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001245 is the FDA 510(k) clearance record for 3T L. V. CONTROL VALVE, a class II device, cleared for 3t Medical Systems, LLC on under FDA product code MJJ (Cpb Check Valve, Retrograde Flow, In-Line). FDA records list 5 510(k) clearances for 3t Medical Systems, LLC, from to . As of , FDA records show 36 recalls naming K001245.

Clearance record

Decision date
Received
(484 days to decision)
Product code
MJJ Cpb Check Valve, Retrograde Flow, In-Line
Regulation
21 CFR 870.4400
Device class
Class II
Review panel
Cardiovascular
Applicant
3t Medical Systems, LLC 6770 Pine Way Dr., Troy MI
510(k) summary
Statement
Third party review
No

Clearances, product code MJJ

Trailing 12 months

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

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