Clearance Summary
6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT received FDA 510(k) clearance under submission number K980127, sponsored by Catheter Innovations, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1998-03-11.
- Submission: K980127
- Applicant / Sponsor: Catheter Innovations, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1998-03-11
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.