FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AcQMap 3D Imaging and Mapping Catheter
K Number: K201341
·
Decision Sep 15, 2020
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
33
Applicant Total
24
Review Days
118
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Basic Information
- Device Name
- AcQMap 3D Imaging and Mapping Catheter
- K Number
- K201341
- 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
- May 20, 2020
- Decision Date
- September 15, 2020
- 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 |
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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 |
| 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 |