510(k) K252652
- Device
- 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
- Applicant
- Fortis Biosolutions Company Limited
- 510(k) number
- K252652
- Product code
- DXT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-14
- Date received
- 2025-08-22
- Regulation
- 870.1650
- Classification name
- Injector And Syringe, Angiographic
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Sharon Au
- Address
- # 121, Ln. 215, Gaoyang S. Rd. Longtan Dist., Taoyuan City TW 325004 325004
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 |
|---|---|---|---|
| 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 |
| K192657 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | 2020-08-07 |