The following data is part of a premarket notification filed by Medtronic Cryocath Lp with the FDA for Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3fc12, 3fc10.
| Device ID | K102176 |
| 510k Number | K102176 |
| Device Name: | FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 |
| Classification | Catheter, Steerable |
| Applicant | MEDTRONIC CRYOCATH LP 16771 CHEMIN STE-MARIE Kirkland, CA H9h5h3 |
| Contact | Kari Lahti |
| Correspondent | Kari Lahti MEDTRONIC CRYOCATH LP 16771 CHEMIN STE-MARIE Kirkland, CA H9h5h3 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-03 |
| Decision Date | 2010-09-01 |
| Summary: | summary |