The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Radia Steerable Diagnostic Catheter.
| Device ID | K091370 |
| 510k Number | K091370 |
| Device Name: | RADIA STEERABLE DIAGNOSTIC CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | C.R. BARD, INC. 55 TECHNOLOGY DRIVE Lowell, MA 01851 |
| Contact | Julia Broderick |
| Correspondent | Julia Broderick C.R. BARD, INC. 55 TECHNOLOGY DRIVE Lowell, MA 01851 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-08 |
| Decision Date | 2009-06-05 |
| Summary: | summary |