510(k) K042541 ยท DQY Catheter, Percutaneous
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
| Applicant | Cryo Vascular Systems, Inc., Los Gatos CA, US |
| Decision | Substantially Equivalent, Oct 12, 2004 |
| Received | Sep 20, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042541
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.