The following data is part of a premarket notification filed by Belmont Instrument Corp. with the FDA for Belmont Model Pbp Intra-aortic Balloon Pump.
| Device ID | K915580 |
| 510k Number | K915580 |
| Device Name: | BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | BELMONT INSTRUMENT CORP. PINEHURST PARK 8 COOK STREET Billerica, MA 01821 |
| Contact | George Herzlinger |
| Correspondent | George Herzlinger BELMONT INSTRUMENT CORP. PINEHURST PARK 8 COOK STREET Billerica, MA 01821 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-26 |
| Decision Date | 1992-10-30 |