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
K984214Substantially Equivalent

Cordis Endovascular Temporary Occlusion Balloon Catheter

Cordis Neurovascular, Inc., Miami Lake FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984214 is the FDA 510(k) clearance record for CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER, a class II device, cleared for Cordis Neurovascular, Inc. on under FDA product code DXC (Clamp, Vascular). FDA records list 38 510(k) clearances for Cordis Neurovascular, Inc., from to . As of , FDA records show no recalls naming K984214.

Clearance record

Decision date
Received
(259 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Cordis Neurovascular, Inc. 14000 NW 57th Ct., Miami Lake FL
510(k) summary
Summary
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