Atlas FDA

Impulse Angiographic Catheter, Expo Angiographic Catheter

FDA 510(k) clearance K152605 · decided 2015-10-29

Clearance details

K-number
K152605
Device name
Impulse Angiographic Catheter, Expo Angiographic Catheter
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2015-09-11
Decision date
2015-10-29
Days to decision
48 days
Clearance type
Special
Product code
DQO
Device class
2
Regulation number
870.1200
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Maple Grove, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; c recall (Z-1638-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; car recall (Z-1639-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; car recall (Z-1640-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; car recall (Z-1641-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; car recall (Z-1642-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; recall (Z-1643-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; ca recall (Z-1644-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712; c recall (Z-1645-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; recall (Z-1646-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902; ca recall (Z-1647-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; ca recall (Z-1648-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; car recall (Z-1649-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; ca recall (Z-1650-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; ca recall (Z-1651-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; card recall (Z-1652-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; c recall (Z-1653-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF H7490852622 recall (Z-1654-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; car recall (Z-1655-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H7490852622 recall (Z-1656-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H7490852623 recall (Z-1657-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; c recall (Z-1658-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H7490852623 recall (Z-1659-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H74908526240 recall (Z-1660-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; c recall (Z-1661-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; car recall (Z-1662-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; recall (Z-1663-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; c recall (Z-1664-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H7490852630 recall (Z-1665-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H74908526 recall (Z-1666-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085 recall (Z-1667-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H7490 recall (Z-1668-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H7490 recall (Z-1669-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H7490 recall (Z-1670-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; card recall (Z-1671-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; card recall (Z-1672-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H7490 recall (Z-1673-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; car recall (Z-1674-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; car recall (Z-1675-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2 recall (Z-1676-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2; recall (Z-1677-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2 recall (Z-1678-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; recall (Z-1679-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; car recall (Z-1680-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; car recall (Z-1681-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; recall (Z-1682-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; car recall (Z-1683-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; car recall (Z-1684-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; card recall (Z-1685-2024)Boston Scientific Corporation2024-05-10

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