510(k) K113769 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
GPSCATH BALLON DILATATION CATHETER
| Applicant | Hotspur Technologies, Mountain View CA, US |
| Decision | Substantially Equivalent, Jan 20, 2012 |
| Received | Dec 22, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113769
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.