Reprocessed PentaRay Nav eco High-Density Mapping Catheter
FDA 510(k) clearance K190785 · decided 2019-06-25
Clearance details
- K-number
- K190785
- Device name
- Reprocessed PentaRay Nav eco High-Density Mapping Catheter
- Applicant
- Innovative Health, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-03-27
- Decision date
- 2019-06-25
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- NLG
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Scottsdale, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled (K212776) | Innovative Health, LLC | 2021-12-20 |
| Reprocessed IntellaMap Orion High Resolution Mapping Catheter (K211662) | Innovative Health, LLC | 2021-11-18 |
Recalls involving this device
No recalls on record reference this clearance.