Clearance Summary
MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT received FDA 510(k) clearance under submission number K875327, sponsored by Schneider-Shilley (Usa). The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1988-03-25.
- Submission: K875327
- Applicant / Sponsor: Schneider-Shilley (Usa)
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1310
- Decision date: 1988-03-25
Classification & Regulation
This clearance is catalogued under FDA product code DRE and 21 CFR 870.1310, within the Cardiovascular review panel as a Class II device.