DQY · Catheter, Percutaneous · Chrysalis Intelligence

Device class

Class II

Regulation 870.1250

Total clearances

122

2020-01-07 → 2026-09-18

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.1250

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
ABBOTT MEDICAL	12	3	2026-06-17
Centerpoint Systems	8	2	2026-07-29
Imds Operations B.V.	7	0	2025-04-17
Reflow Medical, Inc.	7	0	2025-08-22
Medtronic, Inc.	5	1	2025-12-19
Vascular Solutions, LLC	4	0	2022-08-18
Alembic, LLC	4	1	2026-08-12
Boston Scientific Corporation	4	0	2024-02-01
MicroVention, Inc.	3	0	2023-01-10
Cardiovascular Systems, Inc.	3	0	2021-09-24
OrbusNeich Medical (Shenzhen) Co., Ltd.	3	1	2026-04-10
Okami Medical, Inc.	3	0	2024-12-20
Merit Medical Systems, Inc.	3	0	2025-01-15
Transit Scientific, LLC	3	0	2022-04-11
Biotronik, Inc.	3	0	2024-09-12
Vantis Vascular, Inc.	2	1	2026-09-18
C.R. Bard, Inc.	2	0	2022-05-04
Abbott	2	2	2026-07-02
Surmodics,Inc.	2	0	2023-09-29
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular	2	0	2024-05-28
Seigla Medical, Inc.	2	0	2025-04-04
Medtronic Vascular	2	0	2023-08-22
Wallaby Medical	2	0	2023-10-13
Asahi Intecc Co., Ltd.	2	0	2024-06-25
Haolang Medical USA Corporation	1	0	2021-07-07

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.

Code	Type	Description	Confidence	Rationale
36568	CPT	—	Medium	CPT 36568 for percutaneous placement of central venous catheter
36569	CPT	—	Medium	Alternative code for percutaneous central catheter in infant

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-18	K262817	Vantis Vascular, Inc.	CrossFAST Integrated Microcatheter Advanced Delivery System
2026-08-14	K260559	IMDS Operation B.V.	NHanceIT
2026-08-12	K262392	Alembic, LLC	APRO 35 Swift Catheter
2026-07-29	K262240	CenterPoint Systems, LLC	SSPC NXT Delivery Catheter
2026-07-29	K261766	CenterPoint Systems, LLC	CPS Locator 3D Plus Delivery Catheter
2026-07-02	K261825	Abbott	Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter
2026-06-17	K261631	Abbott Medical	Amplatzer TorqVue Exchange System
2026-06-05	K260289	Balosmark, Inc.	Perfect-O Ostial Positioning Catheter
2026-04-24	K260993	Abbott	Amplatzer TorqVue Delivery System
2026-04-10	K253361	OrbusNeich Medical (Shenzhen) Co., Ltd.	Teleport Glide Microcatheter
2026-03-13	K260499	ABBOTT MEDICAL	Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
2025-12-19	K253409	Medtronic, Inc.	C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
2025-12-17	K252417	ABBOTT MEDICAL	Amplatzer Piccolo Delivery System (9-PDS-04F-045)
2025-10-29	K252390	Medtronic, Ireland	Telescope Guide Extension Catheter
2025-08-22	K251277	Reflow Medical, Inc.	CoraForce Microcatheter, CoraFlex Microcatheter
2025-08-22	K250147	Centerpoint Systems	CPS Locator 3D Delivery Catheter
2025-06-29	K250972	Pendracare	Primum Hydrophilic Guiding Catheter
2025-06-27	K250828	CenterPoint Systems, LLC	CPS Locator 3D Plus Delivery Catheter
2025-06-25	K243184	Strait Access Technologies Holdings	SAT CenterFlow Molding Balloon Catheter (IN20-00313)
2025-06-18	K250492	CenterPoint Systems, LLC	FlexiGo 3D Delivery Catheter
2025-06-17	K250219	Bard Peripheral Vascular, Inc.	Dorado PTA Balloon Dilatation Catheter
2025-06-02	K250410	W. L. Gore & Associates, Inc.	GORE® Tri-Lobe Balloon Catheter
2025-05-02	K243757	Shockwave Medical, Inc.	Shockwave CS Guide Catheter
2025-05-01	K251014	Alembic, LLC	APRO 45 Catheter
2025-04-29	K250962	Alembic, LLC	APRO 55 Intermediate Catheter