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 |