The following data is part of a premarket notification filed by Medtronic Cryocath Lp with the FDA for Flexcath Advance Steerable Sheath (12 French).
| Device ID | K123591 |
| 510k Number | K123591 |
| Device Name: | FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) |
| Classification | Catheter, Steerable |
| Applicant | MEDTRONIC CRYOCATH LP 8200 CORAL SEA STREET NE MS MVS46 Mounds View, MN 55112 |
| Contact | Vanessa Ware |
| Correspondent | Vanessa Ware MEDTRONIC CRYOCATH LP 8200 CORAL SEA STREET NE MS MVS46 Mounds View, MN 55112 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-21 |
| Decision Date | 2012-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169688872 | K123591 | 000 |
| 00643169504707 | K123591 | 000 |
| 00763000043773 | K123591 | 000 |