510K并球囊支架.pdfVIP

K122152 F4-5C le.( ? DEC 14 2012 Pre-market Notification for OXTI Inflation Devices 516(k) Summary of Safety and Effectiveness 1. Submitter OXTI Corporation. 8t1hFloor, Unit 146, Jian I Road, Jhonghe District New Taipei City, TAIWAN 23585 Contact: Mr. John Sung Phone: +886 2 2225 4998 Ext. 20 2. Name and Classification of Device Trade Name: OX(TI Inflation Device Common/Usual Name: Balloon inflation syringe Classification Name: Angiographic injector and syringe Regulation Medical Specialty: Cardiovascular Review Panel: Cardiovascular Classification Number: 21CFR 870.1650 Product Code: MAV 3. Predicate Device Trade Name 510(k) Number Decision Date Dolphin Inflation Device K(042449 5/20/2005 Indleflator Plus 30 Priority Pack K(962495 9/12/1996 K122152 4. Device Description The device consists of three major components; a) 30m1 barrel, b)inflation mechanism and c) standard conical fitting and stopcocks system for connecting to the PTCA catheter. The 6% barrel has graduation markings at 0.5m1 interval to the full 30m1 capacity Adual scale pressure gauge mounted at distal end of the barrel iscapable of indicating pressure up to S0atm at latinor l0psi intervals. Reinforced polyurethane tubing extending from the syringe exit port connects to a 6%male/female conical fitting for attaching to the 3-way stopcock and to the angiographic catheter 5. Indications for Use The OXTI Inflation Device is indicated for use during cardiovascular procedures to create, maintain, and monitor pressure in a balloon dilation catheter. 6.Technological Characteristics The 30 ml