GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE— 510(k) K081454
Substantially EquivalentPossis Medical, Inc.
FDA 510(k) clearance K081454 for GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE, Substantially Equivalent on 2008-06-13. Applicant: Possis Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Possis Medical, Inc.
- Product code
- Code MJN
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minneapolis, MN, US
Recent devices under product code MJN
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- 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 MJN
product code MJN- Death
- 31
- Injury
- 240
- Malfunction
- 827
- Total
- 1,098
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.