Reprocessed NRG Transseptal Needle
FDA 510(k) clearance K200060 · decided 2020-07-30
Clearance details
- K-number
- K200060
- Device name
- Reprocessed NRG Transseptal Needle
- Applicant
- Innovative Health, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-01-13
- Decision date
- 2020-07-30
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- QLZ
- Device class
- 2
- Regulation number
- 870.5175
- 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 NRG Transseptal Needle (K213584) | Innovative Health, LLC | 2023-04-04 |
Recalls involving this device
No recalls on record reference this clearance.