The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Preface Guiding Sheath, Models 2-603m, 2-703m, 2-803m, 2-903m, 2-1003m, 2-1103m.
| Device ID | K001139 |
| 510k Number | K001139 |
| Device Name: | PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M |
| Classification | Introducer, Catheter |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Mary Adams |
| Correspondent | Mary Adams BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-05-10 |