510(k) K123264 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
DK-PTCA BALLOON CATHETER
| Applicant | Intuit Medical, LLC, Sugar Hill GA, US |
| Decision | Substantially Equivalent, Jan 16, 2013 |
| Received | Oct 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123264
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.