AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX
FDA 510(k) K193509 · Acutus Medical, Inc.
510(k) numberK193509
Submission
- Device name
- AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX
- Applicant
- Acutus Medical, Inc.
Carlsbad, CA, US - Received
- December 18, 2019
- Decision date
- January 17, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| 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 |
| K221044 | AcQGuide® VUE Steerable SheathDRA · Traditional | 05/05/2022SE |
| 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 |
Questions and answers
When was AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX cleared by the FDA?
AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX (K193509) received a 510(k) decision of Substantially Equivalent on January 17, 2020, 30 days after the submission was received.
What is the product code of K193509?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.