The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Fast-cath 18f Hemostasis Introducer, Model 406xxx.
| Device ID | K001367 |
| 510k Number | K001367 |
| Device Name: | FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX |
| Classification | Introducer, Catheter |
| Applicant | ST. JUDE MEDICAL, INC. 14901 DEVEAU PLACE Minnetonka, MN 55345 |
| Contact | Paul Cornelison |
| Correspondent | Paul Cornelison ST. JUDE MEDICAL, INC. 14901 DEVEAU PLACE Minnetonka, MN 55345 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-01 |
| Decision Date | 2000-05-31 |