510(k) K221917
K221917 is an FDA 510(k) premarket notification submitted by Seven Sons , Ltd. for the device "Stent Positioning Assistance System (SPAS)". The FDA issued a decision of Substantially Equivalent on Aug 19, 2022. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 19, 2022
- Date Received
- Jun 30, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type
- 510(k)