The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Biosense Webster Patient Cable And Leadwires.
| Device ID | K001390 |
| 510k Number | K001390 |
| Device Name: | BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Maria D Ochoa |
| Correspondent | Maria D Ochoa BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-02 |
| Decision Date | 2000-07-21 |