510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171897Substantially Equivalent

Approach CTO Microwire Guide

Cook Incorporated, Bloomington IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171897 is the FDA 510(k) clearance record for Approach CTO Microwire Guide, a class II device, cleared for Cook Incorporated on under FDA product code DQX (Wire, Guide, Catheter). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show 3 recalls naming K171897.

Clearance record

Decision date
Received
(56 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Cook Incorporated 750 Daniels Way, Bloomington IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQX

Trailing 12 months
12 clearances under product code DQX in the twelve months to October 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20263
February 20260
March 20263
April 20260
May 20261
June 20260
July 20262
August 20260
September 20262
October 20260