510(k) K082736
- Device
- RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
- Applicant
- TERUMO MEDICAL CORP.
- 510(k) number
- K082736
- Product code
- DQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-09-24
- Date received
- 2008-09-18
- 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
- MARK UNTERREINER
- Address
- 950 Elkton Blvd. Elkton MD US 21921 21921
FDA Registration Numbers#
- 3010532612
- 3002991496
- 1724474
- 3010432890
- 3006082230
- 3010665433
- 3008496528
- 1016427
- 3016678045
- 3030446844
- 3004519921
- 3013162291
- 3012307300
- 9615817
- 3014590708
- 3006425876
- 3009546466
- 9680794
- 3042190142
- 3008497357
- 3004111573
- 3015910259
- 3012536737
- 3017168767
- 2134244
- 3008692839
- 9612152
- 3020778
- 3006985147
- 2011171
- 2518902
- 8043983
- 3013656790
- 3011050534
- 9616088
- 3030733800
- 1058584
- 3011137372
- 9616684
- 3023245
- 3045816907
- 1043214
- 3012766489
- 8020616
- 3002808467
- 3017262662
- 3005255160
- 3008403546
- 2134812
- 2648045
- 3007836437
- 1713468
- 3014461810
- 3017210488
- 2134265
- 3011237770
- 3007138831
- 1423395
- 1319211
- 3015550451
- 3010041511
- 3009144177
- 2032098
- 3014499739
- 9611665
- 3013556777
- 1721504
- 3004859241
- 9681834
- 1319639
- 2246552
- 2024024
- 1220452
- 1018470
- 3005669815
- 3008700817
- 1054241
- 3008307705
- 3009291251
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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