510(k) K180726
K180726 is an FDA 510(k) premarket notification submitted by Boston Scientific, Inc. for the device "Savion DLVR Guidewire, Savion FLX Guidewire". The FDA issued a decision of Substantially Equivalent on Jun 18, 2018. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Boston Scientific, Inc. has 493 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 18, 2018
- Date Received
- Mar 20, 2018
- 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)