The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Navistar Rmt Steerable Tip Diagnostic Catheter.
| Device ID | K052083 |
| 510k Number | K052083 |
| Device Name: | NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Diana M Thorson |
| Correspondent | Diana M Thorson BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-02 |
| Decision Date | 2005-09-29 |
| Summary: | summary |