# K152605: Impulse Angiographic Catheter, Expo Angiographic Catheter - Pathway: 510(k) (Special) - Applicant: Boston Scientific Corporation - Decided: Oct 29, 2015 after 48 days - Product code: DQO (Catheter, Intravascular, Diagnostic) - Device class: 2 - Regulation: 21 CFR 870.1200 - Recalls of this device: 48 (48 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K934581 (1994). 5 ancestors in all. No later device cites it as a predicate yet. 1 of 6 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K120495: Impulse and Expo Angiographic Catheter, Boston Scientific Corp (2012) Summary page 4. ## Recalls of this device - Mar 21, 2024 · Class I · Z-1666-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1645-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1657-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1670-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1669-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1673-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1667-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1678-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1640-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1664-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1665-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1651-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1677-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1684-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1644-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1648-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1655-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1683-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1661-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1641-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1650-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1639-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1680-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1658-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1643-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1663-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1672-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1679-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1675-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1671-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1646-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1638-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1652-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1676-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1682-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1662-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1653-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1685-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1656-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1674-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1642-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1649-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1654-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1681-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1668-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1660-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1647-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins - Mar 21, 2024 · Class I · Z-1659-2024: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some ins ## Indications for use The Impulse™ and Expo™ Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure. Source page: https://510kreport.com/device/K152605 Methodology: https://510kreport.com/methodology