The following data is part of a premarket notification filed by Medtronic Cryocath Lp with the FDA for Flexcath Advance Steerable Sheath And Dilator.
| Device ID | K202620 |
| 510k Number | K202620 |
| Device Name: | FlexCath Advance Steerable Sheath And Dilator |
| Classification | Catheter, Steerable |
| Applicant | Medtronic CryoCath LP 8200 Coral Sea Street NE, MVS 46 Mounds View, MN 55112 |
| Contact | Matthew Lobeck |
| Correspondent | Matthew Lobeck Medtronic CryoCath LP 8200 Coral Sea Street NE, MVS 46 Mounds View, MN 55112 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-10 |
| Decision Date | 2020-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000418052 | K202620 | 000 |