The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Viewflex Plus Ice Catheter.
| Device ID | K101239 |
| 510k Number | K101239 |
| Device Name: | VIEWFLEX PLUS ICE CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| 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 | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-03 |
| Decision Date | 2010-06-02 |
| Summary: | summary |