510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K002286Substantially Equivalent

Ldob Occlusion Balloon Catheter

Cook Inc., Bloomington IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002286 is the FDA 510(k) clearance record for LDOB OCCLUSION BALLOON CATHETER, a class II device, cleared for Cook, Inc. on under FDA product code MJN (Catheter, Intravascular Occluding, Temporary). FDA records list 163 510(k) clearances for Cook, Inc., from to . As of , FDA records show no recalls naming K002286.

Clearance record

Decision date
Received
(238 days to decision)
Product code
MJN Catheter, Intravascular Occluding, Temporary
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Cook, Inc. 925 S. Curry Pike, Bloomington IN
510(k) summary
Summary
Third party review
No

Clearances, product code MJN

Trailing 12 months

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

FDA records show no clearances under product code MJN in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MJN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260