510(k) K173289
- Device
- Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter And Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter
- Applicant
- Cook Incorporated
- 510(k) number
- K173289
- Product code
- DQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-11-15
- Date received
- 2017-10-16
- Regulation
- 870.1200
- Classification name
- Catheter, Intravascular, Diagnostic
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- David E. Chadwick
- Address
- 750 Daniels Way Bloomington IN US 47402 47402
FDA Registration Numbers#
- 3006131984
- 3010131137
- 3007138831
- 3006950086
- 9616088
- 3004605321
- 1061124
- 3012179728
- 2648045
- 3008692839
- 3009500972
- 8020616
- 8043817
- 3032916632
- 3033589330
- 2134265
- 3008403546
- 3008496528
- 9616684
- 3002807314
- 2528981
- 3021343210
- 2024311
- 3005255160
- 3030447506
- 1721676
- 3003678543
- 3008264254
- 3002991496
- 3006425876
- 3003610571
- 3011137372
- 2024168
- 3016678045
- 3004737415
- 3012050423
- 3004467263
- 3014656749
- 3007048453
- 1123137
- 2648727
- 3012497308
- 3014461810
- 3008114965
- 8010026
- 2025816
- 2011171
- 3009144177
- 3009546466
- 9616099
- 3016171914
- 2183744
- 3013134719
- 3008261722
- 3008363989
- 3006985147
- 1016427
- 3030733800
- 1220477
- 1417592
- 3004122598
- 9612152
- 2134244
- 9681834
- 3013556777
- 3013656790
- 3017210488
- 3029706818
- 3011660785
- 3017262662
- 1646831
- 3011578544
- 2521402
- 3031571797
- 3012279212
- 1060680
- 9615745
- 3023245
- 3010421104
Source Documents#
Other 510(k) Records For Product Code DQO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N | Bioptimal International Pte. , Ltd. | 2026-05-28 |
| K254278 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | 2026-03-25 |
| K250751 | DualView Catheter | Terumo Corporation | 2025-07-17 |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | Gentuity, LLC | 2025-01-31 |
| K242420 | pNOVUS 21 Microcatheter | Phenox, Ltd. | 2024-11-12 |
| K233268 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | 2024-05-22 |
| K233975 | Zoom 6F Insert Catheters | Imperative Care, Inc. | 2024-04-02 |
| K232536 | Soldier Microcatheter | Embolx, Inc. | 2024-02-23 |
| K232573 | INFINITI™ Ambi Angiographic Catheter | Cordis US Corp | 2023-11-21 |
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | Gentuity, LLC | 2023-08-08 |
| K231293 | Drakon™ and Sequre® Microcatheters | Accurate Medical Therapeutics | 2023-06-01 |
| K230411 | Dragonfly OpStar™ Imaging Catheter | ABBOTT MEDICAL | 2023-04-14 |
| K221279 | pNOVUS 21 Microcatheter | Phenox, Ltd. | 2022-11-28 |
| K213666 | NuCath Wedge Pressure Catheter | Pfm Medical, Inc. | 2022-10-06 |
| K221470 | Langston dual lumen catheter | Vascular Solutions, LLC | 2022-06-17 |
Legacy Summary#
summary
FDA Review#
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