The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Redifurl And Teperseal Dl Intra-aortic Balloon Catheters With Hydromer Coating.
| Device ID | K935184 |
| 510k Number | K935184 |
| Device Name: | REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | ST. JUDE MEDICAL, INC. 12 ELIZABETH DR. Chelmsford, MA 01824 |
| Contact | Samuel D Wade |
| Correspondent | Samuel D Wade ST. JUDE MEDICAL, INC. 12 ELIZABETH DR. Chelmsford, MA 01824 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-26 |
| Decision Date | 1995-02-10 |