Clearance Summary
ACUSEAL CARDIOVASCULAR PATCH received FDA 510(k) clearance under submission number K984526, sponsored by W. L. Gore & Associates, 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 1999-04-08.
- Submission: K984526
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3470
- Decision date: 1999-04-08
Classification & Regulation
This clearance is catalogued under FDA product code DXZ and 21 CFR 870.3470, within the Cardiovascular review panel as a Class II device.