510(k) K180677
- Device
- Surefire Spark Infusion System
- Applicant
- Surefire Medical, Inc.
- 510(k) number
- K180677
- Product code
- DQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-04-03
- Date received
- 2018-03-15
- 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
- Yes
Applicant Contact#
- Contact
- Lynne Aronson
- Address
- 6272 W. 91st Ave. Westminster CO US 80031 80031
FDA Registration Numbers#
- 3005595283
- 1000523114
- 3014461810
- 9618000
- 3012766489
- 3030446844
- 2648045
- 3007628272
- 3009746061
- 3012159165
- 3004737415
- 1820334
- 3008853977
- 1000121056
- 1220477
- 2032098
- 3004091615
- 1018470
- 3005255160
- 3013557562
- 3032916632
- 1048735
- 3010291427
- 3012179728
- 2134812
- 3016678045
- 3013134719
- 8020616
- 3015225571
- 3004911384
- 1721504
- 3006082230
- 3012050423
- 3012497308
- 3008573567
- 9617594
- 3014779787
- 1035166
- 9680794
- 2011171
- 1220452
- 3038791046
- 3006985147
- 3012198618
- 3010909876
- 3007138831
- 2029214
- 3004467263
- 3011050534
- 2025816
- 3012279212
- 3003915875
- 1928237
- 3017210488
- 2134244
- 3011642792
- 3029744051
- 3010421104
- 1713468
- 3007289408
- 3004605321
- 9615817
- 3003594449
- 3003610571
- 9681834
- 3030733800
- 3002808467
- 3033589330
- 1061124
- 3010532612
- 2024168
- 2024024
- 3015453963
- 8043983
- 2528981
- 3003678543
- 3030447506
- 2134265
- 3013556777
Source Documents#
Other 510(k) Records For Product Code DQO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261455 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | 2026-06-26 |
| 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 |
Legacy Summary#
summary
FDA Review#
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