ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039— 510(k) K071342
Substantially EquivalentPossis 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.. Device class: 2.
Clearance details
- Applicant
- Possis Medical, Inc.
- Product code
- Code QEZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code QEZ
view allMore clearances from Possis Medical, Inc.
view all- K133629 — ANGIOJET ULTRA AVX THROMBECTOMY SET
- K091593 — ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS
- K090253 — ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001
- K082382 — ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
- K081989 — MODIFICATION TO FETCH ASPIRATION CATHETER
Adverse events under product code QEZ
product code QEZ- Death
- 24
- Total
- 24
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.