The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Orbiter St Diagnostic Electrode Catheter & Orbiter St Extension Cable.
| Device ID | K992373 |
| 510k Number | K992373 |
| Device Name: | ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | C.R. BARD, INC. 55 TECHNOLOGY DR., SUITE 1 Lowell, MA 01851 |
| Contact | Deborah L Herrington |
| Correspondent | Deborah L Herrington C.R. BARD, INC. 55 TECHNOLOGY DR., SUITE 1 Lowell, MA 01851 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-15 |
| Decision Date | 1999-11-05 |
| Summary: | summary |