The following data is part of a premarket notification filed by Cordis Webster, Inc. with the FDA for Cordis Webster Braided Guiding Sheath Exchange System.
| Device ID | K970264 |
| 510k Number | K970264 |
| Device Name: | CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM |
| Classification | Introducer, Catheter |
| Applicant | CORDIS WEBSTER, INC. 4750 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Contact | Mary Adams |
| Correspondent | Mary Adams CORDIS WEBSTER, INC. 4750 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-23 |
| Decision Date | 1997-10-28 |
| Summary: | summary |