AcQGuide® VUE Steerable Sheath
FDA 510(k) K221044 · Acutus Medical, Inc.
510(k) numberK221044
Submission
- Device name
- AcQGuide® VUE Steerable Sheath
- Applicant
- Acutus Medical, Inc.
Carlsbad, CA, US - Received
- April 8, 2022
- Decision date
- May 5, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
| 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 |
| K190167 | MitraClip G4 Steerable Guide CatheterDRA · Special | Abbott | 05/29/2019SE |
More from Abbott
| 510(k) | Device | Decision |
|---|---|---|
| K233691 | FlexCath Cross Transseptal SolutionDYB · Traditional | 12/17/2023SE |
| K231091 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | 07/10/2023SE |
| K230606 | AcQMap® High Resolution Imaging and Mapping SystemDQK · Traditional | 05/02/2023SE |
| K222209 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | 10/17/2022SE |
| K220784 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | 07/01/2022SE |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009MTD · Traditional | 06/21/2022SE |
| K220047 | AcQCross Qx Integrated Transseptal Dilator/NeedleDYB · Traditional | 02/08/2022SE |
| K212345 | AcQMap High Resolution Imaging and Mapping SystemDQK · Special | 08/27/2021SE |
| K210680 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | 08/05/2021SE |
| K211100 | AcQGuide MAX Steerable SheathDRA · Traditional | 05/14/2021SE |
Questions and answers
When was AcQGuide® VUE Steerable Sheath cleared by the FDA?
AcQGuide® VUE Steerable Sheath (K221044) received a 510(k) decision of Substantially Equivalent on May 5, 2022, 27 days after the submission was received.
What is the product code of K221044?
The FDA product code is DRA – Catheter, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1280.