The following data is part of a premarket notification filed by Irvine Biomedical, A St. Jude Medical Company with the FDA for Viewflex Xtra Ice Catheter.
| Device ID | K223077 |
| 510k Number | K223077 |
| Device Name: | ViewFlex Xtra ICE Catheter |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | Irvine Biomedical, A St. Jude Medical Company 2375 Morse Ave Irvine, CA 92614 |
| Contact | Suzanne Pekarna |
| Correspondent | Suzanne Pekarna Irvine Biomedical, A St. Jude Medical Company 2375 Morse Ave Irvine, CA 92614 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-30 |
| Decision Date | 2022-12-07 |