Clearance Summary
PRESSURE CONNECTING TUBE received FDA 510(k) clearance under submission number K131770, sponsored by Shenzhen Ant Hi-Tech Industrial Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-02-26.
- Submission: K131770
- Applicant / Sponsor: Shenzhen Ant Hi-Tech Industrial Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2014-02-26
Classification & Regulation
This clearance is catalogued under FDA product code DQO and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.