510(k) K153685
K153685 is an FDA 510(k) premarket notification submitted by Sunny Medical Device (Shenzhen) Co., Ltd. for the device "Sunmed Haemostatic Valves". The FDA issued a decision of Substantially Equivalent on October 13, 2016. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Sunny Medical Device (Shenzhen) Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 2016
- Date Received
- December 22, 2015
- 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