510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910845Substantially Equivalent

Itc Rotating Hemostatic Valve Cat. No. Mx 1012

Interventional Therapeutics Corp., South San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910845 is the FDA 510(k) clearance record for ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012, a class II device, cleared for Interventional Therapeutics Corp. on under FDA product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass). FDA records list 28 510(k) clearances for Interventional Therapeutics Corp., from to . As of , FDA records show no recalls naming K910845.

Clearance record

Decision date
Received
(83 days to decision)
Product code
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Regulation
21 CFR 870.4290
Device class
Class II
Review panel
Cardiovascular
Applicant
Interventional Therapeutics Corp. 385 Oyster Pt. Blvd., Suite #6, South San Francisco CA
Third party review
No

Clearances, product code DTL

Trailing 12 months

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

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