PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452— 510(k) K984182
Substantially EquivalentPossis Medical, Inc.
FDA 510(k) clearance K984182 for PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452, Substantially Equivalent on 1999-02-01. Applicant: Possis Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Possis Medical, Inc.
- Product code
- Code DSY
- Device class
- Class 2
- Regulation
- 21 CFR 870.3450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code DSY
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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 DSY
product code DSY- Death
- 29
- Injury
- 694
- Total
- 723
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.