510(k) K870387

EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE by American Pharmaseal Div. Ahsc — Product Code BTR

K870387 is an FDA 510(k) premarket notification submitted by American Pharmaseal Div. Ahsc for the device "EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE". The FDA issued a decision of Substantially Equivalent on May 8, 1987. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. American Pharmaseal Div. Ahsc has at least 10 other 510(k) clearances on record.