510(k) K182337
K182337 is an FDA 510(k) premarket notification submitted by Balt USA, LLC for the device "HYBRID Guidewire". The FDA issued a decision of Substantially Equivalent on October 4, 2018. The device falls under product code MOF (Guide, Wire, Catheter, Neurovasculature), a Class II device regulated under 21 CFR 870.1330. Balt USA, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 2018
- Date Received
- August 28, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Guide, Wire, Catheter, Neurovasculature
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- NE
- Submission Type