510(k) K853136 ยท MAV Syringe, Balloon Inflation
MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)
| Applicant | E.A. Fischione Instrument Mfg., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Dec 3, 1985 |
| Received | Jul 26, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853136
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.