ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)
FDA 510(k) clearance K042874 · decided 2004-11-05
Clearance details
- K-number
- K042874
- Device name
- ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)
- Applicant
- Possis Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-10-18
- Decision date
- 2004-11-05
- Days to decision
- 18 days
- Clearance type
- Special
- 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 XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with Ethy recall (Z-0955-2007) | Possis Medical, Inc | 2007-06-21 |
| AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Per recall (Z-0469-06) | Possis Medical, Inc | 2006-02-04 |
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 |