510(k) K140356
K140356 is an FDA 510(k) premarket notification submitted by Sunny Medical Device (Shenzhen) Co., Ltd. for the device "SUMMED HIGH PRESSURE LINE". The FDA issued a decision of Substantially Equivalent on March 20, 2015. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Sunny Medical Device (Shenzhen) Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2015
- Date Received
- February 12, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type