510(k) K230376
K230376 is an FDA 510(k) premarket notification submitted by Innovative Health, LLC for the device "Reprocessed Agilis NxT Steerable Introducer". The FDA issued a decision of Substantially Equivalent on August 7, 2023. The device falls under product code PNE (Reprocessed Catheter Introducer), a Class II device regulated under 21 CFR 870.1340. Innovative Health, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2023
- Date Received
- February 13, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reprocessed Catheter Introducer
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type
Introduce various cardiovascular catheters into the heart and cardiovascular system