DeviceClearance

Roadrunner PC Wire Guide, Olcott Torque Device— 510(k) K182985

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K182985 for Roadrunner PC Wire Guide, Olcott Torque Device, Substantially Equivalent on 2019-07-22. 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

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More clearances from Cook Incorporated

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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 K182985

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 K182985.

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