The following data is part of a premarket notification filed by Medtronic Cryocath Lp with the FDA for Flexcath Select Steerable Sheath (10 French).
| Device ID | K142684 |
| 510k Number | K142684 |
| Device Name: | FlexCath Select Steerable Sheath (10 French) |
| Classification | Introducer, Catheter |
| Applicant | Medtronic CryoCath LP 8200 Coral Sea Street NE Mail Stop MVS46 Mounds View, MN 55112 |
| Contact | Vanessa Ware |
| Correspondent | Vanessa Ware Medtronic CryoCath LP 8200 Coral Sea Street NE Mail Stop MVS46 Mounds View, MN 55112 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-19 |
| Decision Date | 2014-11-06 |
| Summary: | summary |