Clearance Summary
EXTERNAL PACEMAKER WIRE DRESSING CHANGE received FDA 510(k) clearance under submission number K881356, sponsored by Neal & Assoc., 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 1988-05-19.
- Submission: K881356
- Applicant / Sponsor: Neal & Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3680
- Decision date: 1988-05-19
Classification & Regulation
This clearance is catalogued under FDA product code LDF and 21 CFR 870.3680, within the Cardiovascular review panel as a Class II device.