FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
K Number: K212776
·
Decision Dec 20, 2021
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
2
Applicant Total
48
Review Days
110
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Basic Information
- Device Name
- Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
- K Number
- K212776
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovative Health, LLC
- Date Received
- September 1, 2021
- Decision Date
- December 20, 2021
- Product Code
- NLG
- 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 |
|---|---|---|---|
| NLG | Catheter, Intracardiac Mapping, High-Density, Reprocessed | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NLG), ordered by most recent decision date.
Reprocessed IntellaMap Orion High Resolution Mapping Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Reprocessed PentaRay Nav eco High-Density Mapping Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Innovative Health, LLC
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|---|---|---|---|
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| K210655 | Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | May 25, 2022 | Substantially Equivalent |
| K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath | Mar 10, 2022 | Substantially Equivalent |
| K211662 | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | Nov 18, 2021 | Substantially Equivalent |
| K211276 | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters | Sep 15, 2021 | Substantially Equivalent |
| K203655 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) | May 4, 2021 | Substantially Equivalent |