510(k) K042230 ยท DQY Catheter, Percutaneous
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
| Applicant | Cryo Vascular Systems, Inc., Los Gatos CA, US |
| Decision | Substantially Equivalent, Nov 5, 2004 |
| Received | Aug 17, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042230
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.