510(k) K042874 ยท QEZ Aspiration Thrombectomy Catheter
ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)
| Applicant | Possis Medical, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Nov 5, 2004 |
| Received | Oct 18, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042874
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2007 | Possis Medical, Inc Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA-- (XMI - Rapid E Terminated |
DXE | None listed |
| Feb 4, 2006 | Possis Medical, Inc AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use. Sterilized with Ethylene Oxide. Single Use Only. Manufactured and Distributed by: Possis M Terminated |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.