FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
K Number: K233943
·
Decision Mar 8, 2024
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
403
Applicant Total
57
Review Days
85
Basic Information
- Device Name
- Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
- K Number
- K233943
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- December 14, 2023
- Decision Date
- March 8, 2024
- 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 Medtronic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K243435 | Magnetic Localization Patch Kit (AFR-00021) | Dec 5, 2024 | Substantially Equivalent |
| K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit | Nov 1, 2024 | Substantially Equivalent |
| K241259 | Amplatz Goose Neck Snare Kit | Jun 3, 2024 | Substantially Equivalent |
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| K231206 | DLP Silicone Coronary Artery Ostial Cannulae | Dec 7, 2023 | Substantially Equivalent |
| K233562 | LINQ II Insertable Cardiac Monitor | Dec 6, 2023 | Substantially Equivalent |
| K233397 | Cosine-10TM Diagnostic Catheter | Dec 2, 2023 | Substantially Equivalent |
| K233320 | LINQ II Insertable Cardiac Monitor (LNQ22) | Oct 31, 2023 | Substantially Equivalent |