Clearance Summary
VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 received FDA 510(k) clearance under submission number K031844, sponsored by Boston Scientific Corp. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2003-07-15.
- Submission: K031844
- Applicant / Sponsor: Boston Scientific Corp
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 2003-07-15
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.