510(k) K172331
K172331 is an FDA 510(k) premarket notification submitted by Lepu Medical Technology (Beijing) Co., Ltd. for the device "Type I, Type II, Type III, Type IV". The FDA issued a decision of Substantially Equivalent (kit) on March 2, 2018. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Lepu Medical Technology (Beijing) Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- March 2, 2018
- Date Received
- August 2, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type