Chrysalis Intelligence · Product Codes · DXT

DXT · Injector And Syringe, Angiographic

Cardiovascular · 16 clearances · 11 unique sponsors

Device class
Class II
Regulation 870.1650
Total clearances
16
2020-08-07 → 2026-05-14
Last 12 months
7
Unique sponsors
11
Medical specialty
Cardiovascular
Review panel
HO
Regulation number
870.1650
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Acist Medical Systems, Inc. 3 2 2026-05-13
Shenzhen Boon Medical Supply Co., Ltd. 3 0 2024-08-22
Shandong Int Medical Instruments Co., Ltd. 2 1 2025-09-05
Precision Medical Plastics , Ltd. 1 0 2024-06-14
Nemoto Kyorindo Co., Ltd. 1 0 2024-08-27
Shenzhen Maiwei Biotech Co., Ltd. 1 1 2026-04-16
Zhuhai DR Medical Instruments Co., Ltd. 1 1 2026-03-05
Ningbo Dizegens Medical Science Co.,Ltd 1 0 2023-11-21
Youwo (Guangzhou) Medical Device Co., Ltd. 1 0 2020-10-28
Fortis Biosolutions Company Limited 1 1 2026-05-14
Bayer Medical Care, Inc. 1 1 2026-02-13
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
36160 CPT Medium Angiographic injectors are used during coronary/peripheral angiography procedures
A4210 HCPCS Needle-free injection device, each ✓ CMS-verified description Medium Needle and syringe, sterile 1 cc or less, each
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-14 K252652 Fortis Biosolutions Company Limited 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
2026-05-13 K252653 Acist Medical Systems, Inc. ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable
2026-05-13 K252638 Acist Medical Systems, Inc. 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)
2026-04-16 K253048 Shenzhen Maiwei Biotech Co., Ltd. High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
2026-03-05 K251788 Zhuhai DR Medical Instruments Co., Ltd. Extension tube
2026-02-13 K252891 Bayer Medical Care, Inc. MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
2025-09-05 K244038 Shandong Int Medical Instruments Co., Ltd. High Pressure Tubing
2024-12-23 K242143 Shandong Int Medical Instruments Co., Ltd. Angiography Injector
2024-08-27 K242212 Nemoto Kyorindo Co., Ltd. Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)
2024-08-22 K241109 Shenzhen Boon Medical Supply Co., Ltd. Single-use Sterile High-pressure Angiographic Syringes and Accessories
2024-06-14 K230668 Precision Medical Plastics , Ltd. Disposable High-pressure Extension Lines
2023-11-21 K232388 Ningbo Dizegens Medical Science Co.,Ltd High Pressure Tubing
2021-10-19 K211564 Shenzhen Boon Medical Supply Co., Ltd. Sterile High-pressure Angiographic Syringes for Single-use
2020-12-17 K203004 Acist Medical Systems, Inc. ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
2020-10-28 K201395 Youwo (Guangzhou) Medical Device Co., Ltd. Sterile High-pressure Angiographic Syringes for single-use
2020-08-07 K192657 Shenzhen Boon Medical Supply Co., Ltd. Sterile High-pressure Angiographic Syringes for Single-use