POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002— 510(k) K993564
Substantially EquivalentPossis Medical, Inc.
FDA 510(k) clearance K993564 for POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002, Substantially Equivalent on 2000-04-28. Applicant: Possis Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Possis Medical, Inc.
- Product code
- Code MCW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code MCW
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- 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 MCW
product code MCW- Death
- 38
- Injury
- 1,386
- Malfunction
- 2,676
- Other
- 2
- Total
- 4,102
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.