Chrysalis Intelligence · Product Codes · DQO

DQO · Unclassified

21 clearances · 16 unique sponsors

Device class
Regulation —
Total clearances
21
2020-07-29 → 2026-06-26
Last 12 months
3
Unique sponsors
16
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Accurate Medical Therapeutics, Ltd. 3 0 2023-06-01
Phenox, Ltd. 2 0 2024-11-12
Gentuity, LLC 2 0 2025-01-31
Spectrum Vascular 2 2 2026-06-26
Imperative Care, Inc. 1 0 2024-04-02
Vascular Solutions, LLC 1 0 2022-06-17
ABBOTT MEDICAL 1 0 2023-04-14
Suzhou Hengrui Disheng Medical Co., Ltd. 1 0 2020-07-29
Cordis US Corp 1 0 2023-11-21
Terumo Corporation 1 0 2025-07-17
Pfm Medical, Inc. 1 0 2022-10-06
Bioptimal International Pte. , Ltd. 1 1 2026-05-28
Terumo Clinical Supply Co., Ltd. 1 0 2021-12-21
Merit Medical Systems, Inc. 1 0 2024-05-22
Cordis Corporation 1 0 2022-02-17
Embolx, Inc. 1 0 2024-02-23
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
36556 CPT Medium CPT 36556 for insertion of non-tunneled central venous catheter; internal jugular
36557 CPT Medium Alternative code for subclavian or other central venous catheter placement
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-26 K261455 Spectrum Vascular Arterial Pressure Monitoring Set/Tray
2026-05-28 K252702 Bioptimal International Pte. , Ltd. 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
2026-03-25 K254278 Spectrum Vascular Arterial Pressure Monitoring Set/Tray
2025-07-17 K250751 Terumo Corporation DualView Catheter
2025-01-31 K242966 Gentuity, LLC Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
2024-11-12 K242420 Phenox, Ltd. pNOVUS 21 Microcatheter
2024-05-22 K233268 Merit Medical Systems, Inc. Impress Angiographic Catheter
2024-04-02 K233975 Imperative Care, Inc. Zoom 6F Insert Catheters
2024-02-23 K232536 Embolx, Inc. Soldier Microcatheter
2023-11-21 K232573 Cordis US Corp INFINITI™ Ambi Angiographic Catheter
2023-08-08 K230620 Gentuity, LLC Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
2023-06-01 K231293 Accurate Medical Therapeutics Drakon™ and Sequre® Microcatheters
2023-04-14 K230411 ABBOTT MEDICAL Dragonfly OpStar™ Imaging Catheter
2022-11-28 K221279 Phenox, Ltd. pNOVUS 21 Microcatheter
2022-10-06 K213666 Pfm Medical, Inc. NuCath Wedge Pressure Catheter
2022-06-17 K221470 Vascular Solutions, LLC Langston dual lumen catheter
2022-02-17 K212977 Cordis Corporation SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
2021-12-21 K211078 Terumo Clinical Supply Co., Ltd. Progreat Lambda
2020-12-11 K203487 Accurate Medical Therapeutics, Ltd. Drakon and Sequre Microcatheters
2020-10-23 K202797 Accurate Medical Therapeutics, Ltd. Drakon and Sequre Microcatheters
2020-07-29 K193647 Suzhou Hengrui Disheng Medical Co., Ltd. Superpipe Angiographic Catheter