510(k) K182273
- Device
- MEDRAD Stellant FLEX CT Injection System With Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System With Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA,
- Applicant
- Bayer Medical Care Inc.
- 510(k) number
- K182273
- Product code
- DXT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-01
- Date received
- 2018-08-22
- Regulation
- 870.1650
- Classification name
- Injector And Syringe, Angiographic
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lisa A. Ewing
- Address
- 1 Bayer Dr. Indianaola PA US 15051 15051
FDA Registration Numbers#
- 3015173212
- 3034544377
- 3003898360
- 2029275
- 3009882464
- 9610612
- 3011642792
- 2520313
- 1625425
- 3010934635
- 3004068971
- 3004080920
- 3003829571
- 2243252
- 3035858922
- 3007084575
- 1047843
- 2032112
- 3018094310
- 2011171
- 3009196578
- 3014246639
- 1319639
- 3012395857
- 3001650535
- 1054241
- 1928237
- 3011334555
- 3003915875
- 1018470
- 3007138831
- 1721686
- 3002808086
- 3015183635
- 3015009200
- 3015276088
- 3010160527
- 1123137
- 3013764800
- 3007048453
- 1055236
- 2020394
- 3004111573
- 3003561450
- 9610849
- 1643817
- 3009763019
- 3007361214
- 3016096098
- 1061124
- 2936999
- 1526534
- 1518293
- 3012044688
- 3004050971
- 3009504230
- 1526863
- 3013820501
- 2022435
- 1060680
- 2320762
- 1043214
- 3010665433
- 3007007790
- 3011604145
- 3003768277
- 2249018
- 3033589330
- 3006791331
- 3019807891
- 8043817
- 1417592
- 3008850249
- 9616990
- 8022210
- 3004727093
- 3003786696
- 3004753774
- 3010131137
- 1000604079
Source Documents#
Other 510(k) Records For Product Code DXT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr | Fortis Biosolutions Company Limited | 2026-05-14 |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable | Acist Medical Systems, Inc. | 2026-05-13 |
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) | Acist Medical Systems, Inc. | 2026-05-13 |
| K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube | Shenzhen Maiwei Biotech Co., Ltd. | 2026-04-16 |
| K251788 | Extension tube | Zhuhai DR Medical Instruments Co., Ltd. | 2026-03-05 |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | Bayer Medical Care, Inc. | 2026-02-13 |
| K244038 | High Pressure Tubing | Shandong Int Medical Instruments Co., Ltd. | 2025-09-05 |
| K242143 | Angiography Injector | Shandong Int Medical Instruments Co., Ltd. | 2024-12-23 |
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) | Nemoto Kyorindo Co., Ltd. | 2024-08-27 |
| K241109 | Single-use Sterile High-pressure Angiographic Syringes and Accessories | Shenzhen Boon Medical Supply Co., Ltd. | 2024-08-22 |
| K230668 | Disposable High-pressure Extension Lines | Precision Medical Plastics , Ltd. | 2024-06-14 |
| K232388 | High Pressure Tubing | Ningbo Dizegens Medical Science Co.,Ltd | 2023-11-21 |
| K211564 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | 2021-10-19 |
| K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System | Acist Medical Systems, Inc. | 2020-12-17 |
| K201395 | Sterile High-pressure Angiographic Syringes for single-use | Youwo (Guangzhou) Medical Device Co., Ltd. | 2020-10-28 |
Legacy Summary#
summary
FDA Review#
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