The following data is part of a premarket notification filed by Bipore, Inc. with the FDA for Bipore Balloon Dilatation Catheter.
| Device ID | K983650 |
| 510k Number | K983650 |
| Device Name: | BIPORE BALLOON DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | BIPORE, INC. 31 INDUSTRIAL PKWY. Northvale, NJ 07647 |
| Contact | Durmus Koch |
| Correspondent | Durmus Koch BIPORE, INC. 31 INDUSTRIAL PKWY. Northvale, NJ 07647 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-16 |
| Decision Date | 1999-02-17 |
| Summary: | summary |