ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307— 510(k) K071514

Substantially Equivalent

Possis Medical, Inc.

FDA 510(k) clearance K071514 for ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307, 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: 2007-06-04
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.