510(k) K875327

MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT by Schneider-Shilley (Usa) — Product Code DRE

K875327 is an FDA 510(k) premarket notification submitted by Schneider-Shilley (Usa) for the device "MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT". The FDA issued a decision of Substantially Equivalent on March 25, 1988. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Schneider-Shilley (Usa) has at least 8 other 510(k) clearances on record.