Reprocessed NRG Transseptal Needle— 510(k) K213584
Substantially EquivalentInnovative Health, LLC
FDA 510(k) clearance K213584 for Reprocessed NRG Transseptal Needle, Substantially Equivalent on 2023-04-04. Applicant: Innovative Health, LLC. Device class: 2.
Clearance details
- Applicant
- Innovative Health, LLC
- Product code
- Code QLZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5175
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scottsdale, AZ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.