DeviceClearance

Fixed Core Wire Guides— 510(k) K171764

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K171764 for Fixed Core Wire Guides, Substantially Equivalent on 2018-03-09. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant
Cook Incorporated
Product code
Code DQX
Device class
Class 2
Regulation
21 CFR 870.1330
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bloomington, IN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DQX

view all

More clearances from Cook Incorporated

view all

Adverse events under product code DQX

product code DQX
Death
298
Injury
4,385
Malfunction
7,203
Other
5
Total
11,891

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K171764

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171764.

Data sourced from openFDA. This site is unofficial and independent of the FDA.