# P880003: Cordis Ptca Dilatation Catheter - Pathway: PMA - Applicant: Cordis Corp. - Decided: Oct 28, 1988 after 269 days - Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous) - Device class: 2 - Regulation: 21 CFR 870.5100 - Recalls of this device: 80 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage No predicates in its family tree. 29 later devices descend from it; 7 cite it directly. 0 of 30 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. PMA decisions do not claim a predicate device. ## Most influential descendants - K103808: Sapphire NC (2011), 11 descendants of its own - K110133: Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter (2011), 10 descendants of its own - K162209: Sapphire NC Plus (2016), 9 descendants of its own - K111544: Glider Ptca Balloon Catheter (2012), 6 descendants of its own - K103657: Sapphire (2011), 5 descendants of its own ## Recalls of this device - Jan 31, 2011 · Class II · Z-2441-2012: On 1/20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly - Jan 31, 2011 · Class II · Z-2442-2012: On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly - Jan 14, 2008 · Not classified · Z-0773-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0782-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0797-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0761-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0762-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0780-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0791-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0801-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0805-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0802-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0759-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0754-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0766-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0789-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0748-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0772-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0786-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0768-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0799-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0794-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0795-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0775-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0807-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0812-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0750-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0755-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0752-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0760-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0787-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0765-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0757-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0769-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0764-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0776-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0770-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0779-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0790-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0749-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0774-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0793-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0758-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0798-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0784-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0751-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0796-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0756-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0763-2008: Slow Deflation or No Deflation - Jan 14, 2008 · Not classified · Z-0777-2008: Slow Deflation or No Deflation Source page: https://510kreport.com/device/P880003 Methodology: https://510kreport.com/methodology