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 |