510(k) K141707
K141707 is an FDA 510(k) premarket notification submitted by Lepu Medical Technology (Beijing) Co., Ltd. for the device "ULTRASKIN HYDROPHILIC GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on January 21, 2015. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Lepu Medical Technology (Beijing) Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2015
- Date Received
- June 24, 2014
- 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