DeviceClearance

ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire— 510(k) K220654

Substantially Equivalent

Cordis Corporation

FDA 510(k) clearance K220654 for ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire, Substantially Equivalent on 2022-04-06. Applicant: Cordis Corporation. Device class: 2.

Clearance details

Applicant
Cordis Corporation
Product code
Code NTE
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Miami Lakes, FL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code NTE

view all

More clearances from Cordis Corporation

view all

Adverse events under product code NTE

product code NTE
Death
28
Injury
1,348
Malfunction
771
Total
2,147

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 K220654

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 K220654.

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