510(k) K131770
K131770 is an FDA 510(k) premarket notification submitted by Shenzhen Ant Hi-Tech Industrial Co., Ltd. for the device "PRESSURE CONNECTING TUBE". The FDA issued a decision of Substantially Equivalent on February 26, 2014. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Shenzhen Ant Hi-Tech Industrial Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 2014
- Date Received
- June 17, 2013
- 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