Clearance Summary
STRATO PLASTIC PORT INTRO KT(10 FR) LPS 7523/MODIF received FDA 510(k) clearance under submission number K905849, sponsored by Strato Medical Corp.. 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 1991-04-19.
- Submission: K905849
- Applicant / Sponsor: Strato Medical Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 1991-04-19
Classification & Regulation
This clearance is catalogued under FDA product code LJT and 21 CFR 880.5965, within the General Hospital review panel as a Class II device.