Panels › Cardiovascular › Product code DQO · Class 2
Catheter, Intravascular, Diagnostic
Regulation 870.1200
3510(k)s in 12 months (501 all time)
26recalls in 12 months (285 all time)
246recalls that name a 510(k)
Top companies in DQO
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Incorporated | 15 | 85 |
| Boston Scientific Corp | 20 | 73 |
| Merit Medical Systems, Inc. | 8 | 33 |
| Cordis Corp. | 29 | 8 |
| AngioDynamics, Inc. | 11 | 23 |
| Vascular Solutions, Inc. | 12 | 10 |
| C.R. Bard, Inc. | 16 | 0 |
| Scimed Life Systems, Inc. | 16 | 0 |
| LeMaitre Vascular, Inc. | 0 | 12 |
| Target Therapeutics | 10 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF H749085262202; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter Open, Classified |
DQO | K152605 |
| Feb 14, 2024 | Stryker, Inc. Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm Open, Classified |
DQO | K131437 |
| Nov 9, 2023 | Cordis US Corp Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter Open, Classified |
DQO | K970854 |
| Dec 16, 2022 | Cordis US Corp Cordis Angiographic Catheter Extensions.
Used to transport fluid from the power injector to the catheter for injection into the patient. Open, Classified |
DQO | K970854 |
| Jun 3, 2022 | Stryker Neurovascular Trevo Trak 21 Microcatheter, REF: 90338.
TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412;
TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413;
TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414;
TREVO NXT 6X37+TR Open, Classified |
DQO | K192122 |
| May 19, 2022 | Abbott Vascular Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO Open, Classified |
DQO | K192019 |
| Sep 15, 2021 | Cordis Corporation Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C Terminated |
DQO | K992347 |
| Sep 15, 2021 | Cordis Corporation Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B Terminated |
DQO | K992347 |
| Sep 15, 2021 | Cordis Corporation Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A Terminated |
DQO | K992347 |
| Sep 15, 2021 | Cordis Corporation Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB Terminated |
DQO | K992347 |
| Sep 15, 2021 | Cordis Corporation Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB Terminated |
DQO | K992347 |
| Oct 20, 2020 | Vascular Solutions, Inc. Langston Dual Lumen Catheter. Terminated |
DQO | K061565 |
| Oct 20, 2020 | Vascular Solutions, Inc. Langston Dual Lumen Catheter. Terminated |
DQO | K051395 |
| Oct 20, 2020 | Vascular Solutions, Inc. Langston Dual Lumen Catheter. Terminated |
DQO | K051395 |
| Oct 20, 2020 | Vascular Solutions, Inc. Langston Dual Lumen Catheter Terminated |
DQO | K051395 |
| Apr 27, 2020 | Vascular Solutions, Inc. Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies Terminated |
DQO | K051395 |
| Mar 25, 2020 | Boston Scientific Corporation Imager II 5F Angiographic Catheters, 5 units per package. Open, Classified |
DQO | K121694 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
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