The following data is part of a premarket notification filed by Cryocath Technologies, Inc. with the FDA for Flexcath Steerable Sheath & Dilator, Models 3fc10, 3fc12.
| Device ID | K081049 |
| 510k Number | K081049 |
| Device Name: | FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 |
| Classification | Catheter, Steerable |
| Applicant | CRYOCATH TECHNOLOGIES, INC. 52 WEST BASIN RIDGE Galisteo, NM 87540 |
| Contact | Fred Milder |
| Correspondent | Fred Milder CRYOCATH TECHNOLOGIES, INC. 52 WEST BASIN RIDGE Galisteo, NM 87540 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-14 |
| Decision Date | 2008-06-27 |
| Summary: | summary |