510(k) K980957 ยท QEY Mechanical Thrombolysis Catheter
KAPLAN-SIMPSON INFUSASLEEVE II
| Applicant | Localmed, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Jun 10, 1998 |
| Received | Mar 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980957
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.