Clearance Summary
SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS received FDA 510(k) clearance under submission number K112407, sponsored by Smiths Medical MD, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-02-09.
- Submission: K112407
- Applicant / Sponsor: Smiths Medical MD, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 2012-02-09
Classification & Regulation
This clearance is catalogued under FDA product code DYB and 21 CFR 870.1340, within the Cardiovascular review panel as a Class II device.