ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039— 510(k) K071342

Substantially Equivalent

Possis Medical, Inc.

FDA 510(k) clearance K071342 for ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039, Substantially Equivalent on 2007-07-31. Applicant: Possis Medical, Inc..

Clearance details

Applicant: Possis Medical, Inc.
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2007-05-14
Decision date: 2007-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

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.