Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12
FDA 510(k) K081049 · Cryocath Technologies, Inc.
510(k) numberK081049
Submission
- Device name
- Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12
- Applicant
- Cryocath Technologies, Inc.
Galisteo, NM, US - Received
- April 14, 2008
- Decision date
- June 27, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRA – Catheter, Steerable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1280
- Specialty
- Cardiovascular
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| K250529 | Globe Introducer (601-01001)DRA · Traditional | Kardium, Inc. | 06/03/2025SE |
| K233248 | FARADRIVE Steerable SheathDRA · Traditional | Boston Scientific Corporation | 12/11/2023SE |
| K232321 | FlexCath Contour Steerable SheathDRA · Traditional | Medtronic, Inc. | 10/31/2023SE |
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| K221044 | AcQGuide® VUE Steerable SheathDRA · Traditional | Acutus Medical, Inc. | 05/05/2022SE |
| K211100 | AcQGuide MAX Steerable SheathDRA · Traditional | Acutus Medical, Inc. | 05/14/2021SE |
| K202620 | FlexCath Advance Steerable Sheath and DilatorDRA · Traditional | Medtronic Cryocath, LP | 11/13/2020SE |
| K192422 | Steerable Introducer 12FDRA · Traditional | Freudenberg Medical, LLC | 10/04/2019SE |
More from Freudenberg Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K070357 | Flexcath Steerable Sheath & DilatorDRA · Traditional | 12/28/2007SE |
| K062140 | Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1OCL · Special | 08/24/2006SE |
| K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…OCL · Special | 01/13/2006SE |
| K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleOCL · Special | 04/29/2004SE |
| K030303 | Freezor Xtra Surgical Cardiac Cryoablation Device and CCT.2 Cardiac Cardiac Cryoablation…GEH · Traditional | 04/29/2003SE |
Questions and answers
When was Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12 cleared by the FDA?
Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12 (K081049) received a 510(k) decision of Substantially Equivalent on June 27, 2008, 74 days after the submission was received.
What is the product code of K081049?
The FDA product code is DRA – Catheter, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1280.