FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AcQMap 3D Imaging and Mapping Catheter, Model 900009
K Number: K210766
·
Decision Jun 21, 2022
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
33
Applicant Total
24
Review Days
463
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AcQMap 3D Imaging and Mapping Catheter, Model 900009
- K Number
- K210766
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acutus Medical, Inc.
- Date Received
- March 15, 2021
- Decision Date
- June 21, 2022
- Product Code
- MTD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MTD | Catheter, Intracardiac Mapping, High-Density Array | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MTD), ordered by most recent decision date.
OptiMap Catheter - 60mm (OPTI-CATH2-60)
FDA 510(k)
FDA Class 2
·Cardiovascular
OptiMap Catheter - 50mm (OPTI-CATH2-50)
FDA 510(k)
FDA Class 2
·Cardiovascular
Sphere-9Dx Diagnostic Catheter (AFR-00009)
FDA 510(k)
FDA Class 2
·Cardiovascular
Advisor HD Grid X Mapping Catheter, Sensor Enabled
FDA 510(k)
FDA Class 2
·Cardiovascular
PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID
FDA 510(k)
FDA Class 2
·Cardiovascular
Ablacath Mapping Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Acutus Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233691 | FlexCath Cross Transseptal Solution | Dec 17, 2023 | Substantially Equivalent |
| K231091 | AcQMap High Resolution Imaging and Mapping System | Jul 10, 2023 | Substantially Equivalent |
| K230606 | AcQMap® High Resolution Imaging and Mapping System | May 2, 2023 | Substantially Equivalent |
| K222209 | AcQMap High Resolution Imaging and Mapping System | Oct 17, 2022 | Substantially Equivalent |
| K220784 | AcQMap High Resolution Imaging and Mapping System | Jul 1, 2022 | Substantially Equivalent |
| K221044 | AcQGuide® VUE Steerable Sheath | May 5, 2022 | Substantially Equivalent |
| K220047 | AcQCross Qx Integrated Transseptal Dilator/Needle | Feb 8, 2022 | Substantially Equivalent |
| K212345 | AcQMap High Resolution Imaging and Mapping System | Aug 27, 2021 | Substantially Equivalent |
| K210680 | AcQMap High Resolution Imaging and Mapping System | Aug 5, 2021 | Substantially Equivalent |
| K211100 | AcQGuide MAX Steerable Sheath | May 14, 2021 | Substantially Equivalent |