510(k) K230411
- Device
- Dragonfly OpStar Imaging Catheter
- Applicant
- ABBOTT MEDICAL
- 510(k) number
- K230411
- Product code
- DQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-14
- Date received
- 2023-02-15
- Regulation
- 870.1200
- Classification name
- Catheter, Intravascular, Diagnostic
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Derek Pike
- Address
- 4 Robbins Rd. Westford MA US 01886 01886
FDA Registration Numbers
- 3017168767
- 3010665433
- 3014499739
- 2521402
- 9710602
- 1061124
- 3008307705
- 3006131984
- 3010909876
- 3015453963
- 2183744
- 3010291427
- 3006985147
- 3012536737
- 3004122598
- 2032098
- 2134265
- 1018470
- 8043983
- 3008700817
- 1318694
- 3012497308
- 3031571797
- 3015550451
- 3005012805
- 3030447506
- 2648727
- 3013557562
- 9616099
- 2024168
- 2246552
- 3010131137
- 3032534
- 9616684
- 3004467263
- 1423537
- 1721676
- 1820334
- 3015910259
- 3006425876
- 3006950086
- 3012307300
- 3003678543
- 1317547
- 3033589330
- 3013162291
- 3006891665
- 3010079067
- 3002991496
- 3017210488
- 3003915875
- 2024024
- 3002807314
- 3008692839
- 3007628272
- 3012159165
- 3011416394
- 3017262662
- 1018233
- 3008403546
- 3012766489
- 1423395
- 3038791046
- 3030733800
- 9612152
- 3003594449
- 3023245
- 1422634
- 1625425
- 3014656749
- 3013656790
- 3020778
- 1043214
- 3013134719
- 3007048453
- 1055236
- 3026788751
- 3005669815
- 3030714660
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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| 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 |
| 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 |
| K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | Cordis Corporation | 2022-02-17 |
| K211078 | Progreat Lambda | Terumo Clinical Supply Co., Ltd. | 2021-12-21 |