ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT— 510(k) K040013
Substantially EquivalentPossis Medical, Inc.
FDA 510(k) clearance K040013 for ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT, Substantially Equivalent on 2004-05-18. 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
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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.