NKQClass II

Guidewire, Catheter, Reprocessed

Cardiovascular · 21 CFR 870.1330

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

MDR events4All time

Recalls1All time

Registered firms4Currently listed

510(k) clearances0All time

Recent MDR events

4 adverse event reports on file

See all →

Event type breakdown

Malfunction2

Death1

Injury1

Most-reported manufacturers

See all →

Abiomed, Inc.1 Band Endoscopic Technologies C.b.bard. Inc.1 Boston Scientific Cardiology1 Covidien1

Recalls

1 recall events for this product code

See all →

Medtronic Vascular
TerminatedJun 16, 2021
Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004,
The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.
Z-1860-2021 · View FDA record ↗

Registered firms

4 firms currently registered for this product code

See all →

510(k) clearances

0 clearances for this product code

See all →

No 510(k) clearances on file for this product code.