ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE— 510(k) K101651

Substantially Equivalent

Cordis Corp.

FDA 510(k) clearance K101651 for ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE, Substantially Equivalent on 2010-07-09. Applicant: Cordis Corp..

Clearance details

Applicant: Cordis Corp.
Product code: Code NTE
Advisory panel: Cardiovascular
Date received: 2010-06-11
Decision date: 2010-07-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Bridgewater, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NTE

product code NTE

Death: 28
Injury: 1,348
Malfunction: 771
Total: 2,147

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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