510(k) K120119
K120119 is an FDA 510(k) premarket notification submitted by Sunny Medical Device (Shenzhen) Co., Ltd. for the device "SUNMED GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on May 11, 2012. 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
- May 11, 2012
- Date Received
- January 17, 2012
- 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