The following data is part of a premarket notification filed by Bipore, Inc. with the FDA for Biopore Balloon Dilation Catheter.
| Device ID | K041293 |
| 510k Number | K041293 |
| Device Name: | BIOPORE BALLOON DILATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | BIPORE, INC. 31 INDUSTRIAL PKWY. Northvale, NJ 07647 |
| Contact | Keith Paluch |
| Correspondent | Keith Paluch BIPORE, INC. 31 INDUSTRIAL PKWY. Northvale, NJ 07647 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-14 |
| Decision Date | 2004-07-09 |
| Summary: | summary |