510(k) K011217
- Device
- CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K011217
- Product code
- DQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-05-16
- Date received
- 2001-04-20
- Regulation
- 870.1200
- Classification name
- Catheter, Intravascular, Diagnostic
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS P SAMPOGNA
- Address
- Dept. 389, Ap30 200 Abbott Park Rd. Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 1123137
- 9615817
- 3032916632
- 3008497357
- 3030447506
- 3003678543
- 1018233
- 3021343210
- 2134265
- 3005595283
- 9680794
- 3031571797
- 3004091615
- 3042190142
- 1060680
- 3007361214
- 2011171
- 3012279212
- 1625425
- 1061124
- 8043817
- 3012307300
- 3010041511
- 3006131984
- 3003594449
- 3013162291
- 3010432890
- 3013351723
- 3002808466
- 3010131137
- 9612152
- 3015859709
- 3015173212
- 3012536737
- 3004111573
- 3009965866
- 1000121056
- 3014779787
- 3015453963
- 1318694
- 3011050534
- 2030624
- 2024168
- 8020785
- 1724474
- 3004519921
- 3033589330
- 8010026
- 3013764800
- 3002991496
- 2320762
- 3023245
- 1054241
- 3007830707
- 3009500972
- 2124215
- 3012497308
- 2183744
- 9611665
- 9617594
- 3008261722
- 3008307705
- 3002808467
- 2024024
- 3012931345
- 3015910259
- 3005669815
- 1928237
- 3010079067
- 3012159165
- 3012179728
- 3006891665
- 3007048453
- 3015309643
- 3011660785
- 1319639
- 2024311
- 3038791046
- 3008853977
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
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