510(k) K242420
- Device
- pNOVUS 21 Microcatheter
- Applicant
- Phenox, Ltd.
- 510(k) number
- K242420
- Product code
- DQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-11-12
- Date received
- 2024-08-15
- 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
- No
Applicant Contact#
- Contact
- Rachel McDaid
- Address
- Kamrick Ct. Ballybrit Business Park Galway IE H91XY38 H91XY38
FDA Registration Numbers#
- 3008573567
- 9710602
- 3015173212
- 3012050423
- 9617601
- 3008496528
- 1423537
- 1318694
- 9617594
- 2024311
- 3006425876
- 3003898360
- 2029275
- 2024024
- 2528981
- 3014656749
- 3013656790
- 3010532612
- 3038791046
- 3008363989
- 3032534
- 3011642792
- 9618000
- 2134244
- 3009965866
- 1423395
- 3002807314
- 9616099
- 1625425
- 3006891665
- 3007628272
- 1000121056
- 3011416394
- 3009600098
- 9612126
- 8020616
- 3011237770
- 2025816
- 3007830707
- 3003289723
- 3017168767
- 3013162291
- 2032112
- 1047843
- 9616088
- 2011171
- 3009144177
- 3006985147
- 3012497308
- 1048735
- 1319639
- 1018233
- 3003678543
- 1054241
- 3013351723
- 3008853977
- 1928237
- 3012931345
- 3008700817
- 3012766489
- 3003915875
- 1018470
- 3007138831
- 3031571797
- 3012279212
- 1721686
- 3029706818
- 9611665
- 3004519921
- 9616684
- 3014590708
- 1220477
- 3008497357
- 3003610571
- 3016171914
- 1422634
- 2124215
- 1123137
- 3008307705
Source Documents#
Other 510(k) Records For Product Code DQO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| 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 |