The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Seal-away Cs Introducer Kit, Models 407514, 407515.
| Device ID | K013029 |
| 510k Number | K013029 |
| Device Name: | SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 |
| Classification | Introducer, Catheter |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Contact | Jim M Taufen |
| Correspondent | Jim M Taufen 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 | 2001-09-10 |
| Decision Date | 2001-10-09 |
| Summary: | summary |