510(k) K101047 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
PTA-DUO PTA BALLOON CATHETER
| Applicant | Hotspur Technologies, Mountain View CA, US |
| Decision | Substantially Equivalent, Jul 13, 2010 |
| Received | Apr 14, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101047
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.