Clearance Summary
MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 received FDA 510(k) clearance under submission number K022117, sponsored by Merit Medical Systems, 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 2002-10-11.
- Submission: K022117
- Applicant / Sponsor: Merit Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1390
- Decision date: 2002-10-11
Classification & Regulation
This clearance is catalogued under FDA product code DRC and 21 CFR 870.1390, within the Cardiovascular review panel as a Class II device.