The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Orbiter Pv Diagnostic Electrode Catheter, Models 320100 & 320110.
| Device ID | K030627 |
| 510k Number | K030627 |
| Device Name: | ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110 |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | C.R. BARD, INC. 55 TECHNOLOGY DR. Lowell, MA 01851 |
| Contact | Deborah Herrington |
| Correspondent | Deborah Herrington C.R. BARD, INC. 55 TECHNOLOGY DR. 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 | 2003-02-27 |
| Decision Date | 2003-10-23 |
| Summary: | summary |