Clearance Summary
ENVOY GUIDING CATHETER received FDA 510(k) clearance under submission number K140307, sponsored by Codman & Shurtleff, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-04-21.
- Submission: K140307
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2014-04-21
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.