The following data is part of a premarket notification filed by St. Jude Medical, Daig Division, Inc. with the FDA for Apeel Cs Plus Catheter Delivery System, Models 407579, 407580, 407581, 407582.
Device ID | K051096 |
510k Number | K051096 |
Device Name: | APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582 |
Classification | Introducer, Catheter |
Applicant | ST. JUDE MEDICAL, DAIG DIVISION, INC. 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
Contact | Mike Burnside |
Correspondent | Mike Burnside ST. JUDE MEDICAL, DAIG DIVISION, INC. 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
Product Code | DYB |
CFR Regulation Number | 870.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-04-29 |
Decision Date | 2005-05-17 |
Summary: | summary |