510(k) K193653
K193653 is an FDA 510(k) premarket notification submitted by Suzhou Hengrui Disheng Medical Co., Ltd. for the device "Hydrophilic Coating Guide Wire". The FDA issued a decision of Substantially Equivalent on Aug 26, 2020. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Suzhou Hengrui Disheng Medical Co., Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 26, 2020
- Date Received
- Dec 30, 2019
- 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)