510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K921399Substantially Equivalent

Occlusion Ballon Catheter Modificaion

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

K921399 is the FDA 510(k) clearance record for OCCLUSION BALLON CATHETER MODIFICAION, a class II device, cleared for Interventional Therapeutics Corp. on under FDA product code DXC (Clamp, Vascular). FDA records list 28 510(k) clearances for Interventional Therapeutics Corp., from to . As of , FDA records show no recalls naming K921399.

Clearance record

Decision date
Received
(185 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Interventional Therapeutics Corp. 385 Oyster Pt. Blvd., Suite #6, South San Francisco CA
510(k) summary
Statement
Third party review
No

Clearances, product code DXC

Trailing 12 months
6 clearances under product code DXC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20261
July 20261
August 20260
September 20260
October 20260