FlexCath Advance Steerable Sheath and Dilator
FDA 510(k) K202620 · Medtronic Cryocath, LP
510(k) numberK202620
Submission
- Device name
- FlexCath Advance Steerable Sheath and Dilator
- Applicant
- Medtronic Cryocath, LP
Minneapolis, MN, US - Received
- September 10, 2020
- Decision date
- November 13, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code DRA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402)DRA · Special | Boston Scientific Corporation | 07/24/2026SE |
| 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 |
| K223824 | POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping…DRA · Traditional | Boston Scientific Corporation | 03/22/2023SE |
| K221397 | MitraClip G4 Steerable Guide CatheterDRA · Special | Abbott Medical | 09/28/2022SE |
| K221044 | AcQGuide® VUE Steerable SheathDRA · Traditional | Acutus Medical, Inc. | 05/05/2022SE |
| K211100 | AcQGuide MAX Steerable SheathDRA · Traditional | Acutus Medical, Inc. | 05/14/2021SE |
| K192422 | Steerable Introducer 12FDRA · Traditional | Freudenberg Medical, LLC | 10/04/2019SE |
| K190167 | MitraClip G4 Steerable Guide CatheterDRA · Special | Abbott | 05/29/2019SE |
More from Abbott
| 510(k) | Device | Decision |
|---|---|---|
| K183174 | FlexCath Advance Steerable Sheath and DilatorDRA · Traditional | 11/26/2018SE |
| K163268 | FlexCath Select Steerable Shealth and DilatorDYB · Traditional | 02/02/2017SE |
| K142684 | FlexCath Select Steerable Sheath (10 French)DYB · Traditional | 11/06/2014SE |
| K123591 | Flexcath Advance Steerable Sheath (12 French)DRA · Special | 12/27/2012SE |
| K102176 | Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model…DRA · Special | 09/01/2010SE |
Questions and answers
When was FlexCath Advance Steerable Sheath and Dilator cleared by the FDA?
FlexCath Advance Steerable Sheath and Dilator (K202620) received a 510(k) decision of Substantially Equivalent on November 13, 2020, 64 days after the submission was received.
What is the product code of K202620?
The FDA product code is DRA – Catheter, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1280.