FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AcQMap High Resolution Imaging and Mapping System
K Number: K212345
·
Decision Aug 27, 2021
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
24
Review Days
30
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Basic Information
- Device Name
- AcQMap High Resolution Imaging and Mapping System
- K Number
- K212345
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acutus Medical, Inc.
- Date Received
- July 28, 2021
- Decision Date
- August 27, 2021
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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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 |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009 | Jun 21, 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 |
| K210680 | AcQMap High Resolution Imaging and Mapping System | Aug 5, 2021 | Substantially Equivalent |
| K211100 | AcQGuide MAX Steerable Sheath | May 14, 2021 | Substantially Equivalent |