ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS
FDA 510(k) clearance K072769 · decided 2007-11-14
Clearance details
- K-number
- K072769
- Device name
- ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS
- Applicant
- Possis Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-28
- Decision date
- 2007-11-14
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- QEZ
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Steri recall (Z-2377-2015) | Boston Scientific Corporation | 2015-08-13 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| POSSIS PERMA-SEAL DIALYSIS ACCESS GRAFT (P980017/S001) | Possis Medical, Inc. | 1999-03-24 |
| PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20 (P980017) | Possis Medical, Inc. | 1998-09-25 |