510(k) K213584
K213584 is an FDA 510(k) premarket notification submitted by Innovative Health, LLC for the device "Reprocessed NRG Transseptal Needle". The FDA issued a decision of Substantially Equivalent on April 4, 2023. The device falls under product code QLZ (Septostomy Catheter, Reprocessed), a Class II device regulated under 21 CFR 870.5175. Innovative Health, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2023
- Date Received
- November 12, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Septostomy Catheter, Reprocessed
- Device Class
- Class II
- Regulation Number
- 870.5175
- Review Panel
- CV
- Submission Type
To create or enlarge an atrial septal defect in the heart.