The following data is part of a premarket notification filed by Medtronic Cryocath Lp with the FDA for Flexcath Select Steerable Shealth And Dilator.
| Device ID | K163268 |
| 510k Number | K163268 |
| Device Name: | FlexCath Select Steerable Shealth And Dilator |
| Classification | Introducer, Catheter |
| Applicant | Medtronic CryoCath LP 8200 Coral Sea Street NE, Mail Stop MVS46 Mail Stop MVS46 Mounds View, MN 55112 |
| Contact | Natalie Sadeghi |
| Correspondent | Natalie Sadeghi Medtronic CryoCath LP 8200 Coral Sea Street NE, Mail Stop MVS46 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 | 2016-11-21 |
| Decision Date | 2017-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169688858 | K163268 | 000 |
| 00763000279905 | K163268 | 000 |