The following data is part of a premarket notification filed by Bipore, Inc. with the FDA for Bipore Accuflex Percutaneous Sheath Introducer.
| Device ID | K073434 |
| 510k Number | K073434 |
| Device Name: | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-06 |
| Decision Date | 2008-04-01 |
| Summary: | summary |