510(k) K171665
K171665 is an FDA 510(k) premarket notification submitted by Suzhou Hengrui Disheng Medical Co., Ltd. for the device "Microcatheter and guide-wire system". The FDA issued a decision of Substantially Equivalent on Jan 11, 2018. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Suzhou Hengrui Disheng Medical Co., Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 11, 2018
- Date Received
- Jun 5, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Continuous Flush
- Device Class
- Class II
- Regulation Number
- 870.1210
- Review Panel
- CV
- Submission Type
- 510(k)