510(k) K150603

Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube by Teleflexmedical, Inc. — Product Code BTR

K150603 is an FDA 510(k) premarket notification submitted by Teleflexmedical, Inc. for the device "Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube". The FDA issued a decision of Substantially Equivalent on November 27, 2015. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Teleflexmedical, Inc. has at least 10 other 510(k) clearances on record.