510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895044Substantially Equivalent

Dual Guide Introducer Catheter

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

K895044 is the FDA 510(k) clearance record for DUAL GUIDE INTRODUCER CATHETER, a class II device, cleared for Cook, Inc. on under FDA product code DYB (Introducer, Catheter). FDA records list 163 510(k) clearances for Cook, Inc., from to . As of , FDA records show no recalls naming K895044.

Clearance record

Decision date
Received
(201 days to decision)
Product code
DYB Introducer, Catheter
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Applicant
Cook, Inc. 925 S. Curry Pike, Bloomington IN
Third party review
No

Clearances, product code DYB

Trailing 12 months
19 clearances under product code DYB in the twelve months to November 2026, April 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code DYB, trailing twelve months
MonthClearances
December 20252
January 20261
February 20262
March 20261
April 20267
May 20260
June 20263
July 20262
August 20260
September 20260
October 20261
November 20260