Clearance Summary
CODMAN BACTISEAL CATHETERS received FDA 510(k) clearance under submission number K003322, sponsored by Codman & Shurtleff, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-10-01.
- Submission: K003322
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4100
- Decision date: 2001-10-01
Classification & Regulation
This clearance is catalogued under FDA product code HCA and 21 CFR 882.4100, within the Neurology review panel as a Class II device.