510(k) K213584
- Device
- Reprocessed NRG Transseptal Needle
- Applicant
- Innovative Health, LLC
- 510(k) number
- K213584
- Product code
- QLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-04
- Date received
- 2021-11-12
- Regulation
- 870.5175
- Classification name
- Septostomy Catheter, Reprocessed
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Rick Ferreira
- Address
- 1435 N. Hayden Rd. Suite 100 Scottsdale AZ US 85257 85257
FDA Registration Numbers#
- 3011610434
Source Documents#
Other 510(k) Records For Product Code QLZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200060 | Reprocessed NRG Transseptal Needle | Innovative Health, LLC | 2020-07-30 |