PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20
FDA premarket approval P980017 · decided 1998-09-25
Approval details
- PMA number
- P980017
- Trade name
- PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20
- Applicant
- Possis Medical, Inc.
- Date received
- 1997-12-12
- Decision date
- 1998-09-25
- Days to decision
- 287 days
- Decision code
- APWD
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Minneapolis, MN
- Statement
- Approval for the Possis Perma-Seal(R) Dialysis Access Graft, Model 2C20-B. This device is indicated for use as a subcutaneous arteriovenous shunt graft to provide immediate and subsequent chronic blood access for high-efficiency hemodialysis in patients who meet one or more of the following conditons: 1) central venous cannulation is deemed hazardous or is technically unavailable; 2) are being maintained on chronic anticoagulation or antithrombotic therapy; and/or 3) are morbidly obese.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ANGIOJET ULTRA AVX THROMBECTOMY SET (K133629) | Possis Medical, Inc. | 2014-02-14 |
| ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS (K091593) | Possis Medical, Inc. | 2009-06-22 |
| ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001 (K090253) | Possis Medical, Inc. | 2009-04-08 |
| ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 (K082382) | Possis Medical, Inc. | 2008-12-12 |
| MODIFICATION TO FETCH ASPIRATION CATHETER (K081989) | Possis Medical, Inc. | 2008-09-26 |
| GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE (K081454) | Possis Medical, Inc. | 2008-06-13 |
| ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 (K080806) | Possis Medical, Inc. | 2008-04-04 |
| ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 (K073441) | Possis Medical, Inc. | 2008-01-24 |