The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Apeel Cs Catheter Delivery System.
| Device ID | K031906 |
| 510k Number | K031906 |
| Device Name: | APEEL CS CATHETER DELIVERY SYSTEM |
| Classification | Introducer, Catheter |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Contact | Mike Burnside |
| Correspondent | Mike Burnside ST. JUDE MEDICAL 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 | 2003-06-20 |
| Decision Date | 2003-07-18 |
| Summary: | summary |