510(k) K232574
K232574 is an FDA 510(k) premarket notification submitted by Filmec Co. , Ltd. for the device "VASSALLO GT Crossing14". The FDA issued a decision of Substantially Equivalent on October 11, 2023. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Filmec Co. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 11, 2023
- Date Received
- August 25, 2023
- Clearance Type
- Special
- 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