510(k) K203529
K203529 is an FDA 510(k) premarket notification submitted by Filmecc Co., Ltd. for the device "VASSALLO GT Hybrid". The FDA issued a decision of Substantially Equivalent on May 4, 2021. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Filmecc Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2021
- Date Received
- December 2, 2020
- 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