Clearance Summary
PRELUDE SHEATH INTRODUCER received FDA 510(k) clearance under submission number K130791, sponsored by Merit Medical Systems, 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 2013-06-07.
- Submission: K130791
- Applicant / Sponsor: Merit Medical Systems, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1310
- Decision date: 2013-06-07
Classification & Regulation
This clearance is catalogued under FDA product code DRE and 21 CFR 870.1310, within the Cardiovascular review panel as a Class II device.