510(k) K221846
K221846 is an FDA 510(k) premarket notification submitted by Inari Medical for the device "Artix Ballon Guiding Sheath". The FDA issued a decision of Substantially Equivalent on Jul 11, 2022. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Inari Medical has 57 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 11, 2022
- Date Received
- Jun 24, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)