The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Viewflex Xtra Ice Catheter.
| Device ID | K121381 |
| 510k Number | K121381 |
| Device Name: | VIEWFLEX XTRA ICE CATHETER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ST. JUDE MEDICAL One St. Jude Medical Drive St. Paul, MN 55117 |
| Contact | Loucinda Bjorklund |
| Correspondent | Loucinda Bjorklund ST. JUDE MEDICAL One St. Jude Medical Drive St. Paul, MN 55117 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-08 |
| Decision Date | 2012-06-07 |
| Summary: | summary |