510(k) K152605 ยท DQO Catheter, Intravascular, Diagnostic
Impulse Angiographic Catheter, Expo Angiographic Catheter
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Oct 29, 2015 |
| Received | Sep 11, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152605
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF H749085262202; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter Open, Classified |
DQO | None listed |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter Open, Classified |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.