510(k) K221279
K221279 is an FDA 510(k) premarket notification submitted by Phenox, Ltd. for the device "pNOVUS 21 Microcatheter". The FDA issued a decision of Substantially Equivalent on November 28, 2022. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Phenox, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 2022
- Date Received
- May 3, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type