Clearance Summary
PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER received FDA 510(k) clearance under submission number K883607, 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 1988-09-30.
- Submission: K883607
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.4545
- Decision date: 1988-09-30
Classification & Regulation
This clearance is catalogued under FDA product code GYK and 21 CFR 882.4545, within the Neurology review panel as a Class I device.