DYB · Introducer, Catheter · Chrysalis Intelligence

Device class

Class II

Regulation 870.1340

Total clearances

2020-01-06 → 2026-07-29

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.1340

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
Argon Medical Devices	8	1	2025-12-15
CenterPoint Systems, LLC	6	3	2026-06-05
Abiomed, Inc.	5	1	2025-10-08
Inari Medical, Inc.	4	1	2025-12-17
Boston Scientific Corporation	4	0	2025-03-20
Contract Medical International, GmbH	4	0	2025-03-16
Acutus Medical, Inc.	4	0	2023-12-17
ABBOTT MEDICAL	4	0	2024-12-13
Merit Medical Systems, Inc.	4	0	2025-04-25
Edwards Lifesciences	4	1	2026-04-17
Baylis Medical Company, Inc.	3	0	2023-12-20
Cardiocycle Medical(Suzhou) Co., Ltd.	2	2	2026-04-23
Shanghai Microport EP Medtech Co., Ltd.	2	0	2022-03-23
East End Medical I, LLC	2	0	2024-09-06
Circa Scientific, Inc.	2	0	2025-04-24
Surmodics,Inc.	2	0	2025-09-24
Beijing Demax Medical Technology Co.,Ltd	2	0	2024-08-22
Vizaramed, Inc.	2	1	2026-03-26
Cordis US Corp	1	0	2023-04-24
Jupiter Endovascular	1	0	2025-09-12
Dib Ultranav Medical, LLC	1	0	2022-03-24
AtriCure, Inc.	1	0	2024-02-13
Protaryx Medical, Inc.	1	1	2026-04-10
Cook Medical	1	0	2024-03-25
Togo Medikit Co., Ltd.	1	0	2024-09-17

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	—	High	Insertion of peripherally inserted central venous catheter (PICC), without subcutaneous port or pump, including imaging guidance
36569	CPT	—	High	Insertion of peripherally inserted central venous catheter (PICC), with subcutaneous port

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-29	K253526	Medline Industries, LP	NAMIC Dilator and Sheath
2026-07-06	K261529	Hartman Medical Group, LLC	Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)
2026-06-25	K261242	Pendracare	SimplGuide
2026-06-22	K261950	Health Line International Corporation	Health Line Tearaway Introducer
2026-06-05	K261492	CenterPoint Systems, LLC	FieldFlex Steerable Sheath
2026-04-29	K260606	Echo Medical, LLC	Echo Large Bore Introducer Sheath
2026-04-23	K254248	Cardiocycle Medical(Suzhou) Co., Ltd.	Introducer Sheath Set
2026-04-17	K254279	Edwards Lifesciences	Edwards eSheath+ introducer set
2026-04-13	K260091	Inquis Medical	Aventus Introducer Sheath
2026-04-10	K260839	Protaryx Medical, Inc.	Protaryx Transseptal Puncture Device (PTX2-001)
2026-04-07	K260942	CenterPoint Systems, LLC	AuST Steerable Sheath
2026-04-06	K260459	Zoll Respicardia, Inc.	VANES Delivery System (VDS)
2026-03-26	K260626	Vizaramed, Inc.	Multiflex Steerable Sheath 17.5F
2026-02-19	K260163	CenterPoint Systems, LLC	AuST CSP Introducer
2026-02-09	K254236	VascuTech Medical, LLC	Peel-Away Introducer Sheath
2026-01-22	K253652	Cultiv8 1, LLC	Genie MAX Large Bore Introducer Sheath
2025-12-17	K252508	Inari Medical, Inc.	Intri26 Introducer Sheath
2025-12-15	K253741	Argon Medical Devices, Inc.	VStick Vascular Access Set
2025-10-23	K252309	Vivasure Medical Limited	PerQseal Introducers
2025-10-21	K251838	Cardiocycle Medical(Suzhou) Co., Ltd.	Introducer Sheath Set
2025-10-08	K252766	Abiomed, Inc.	14Fr Low Profile Introducer Kit
2025-09-29	K252441	South53, LLC	Primero Safe Access System
2025-09-24	K252227	Surmodics,Inc.	Pounce(TM) Sheath
2025-09-12	K252027	Jupiter Endovascular	Vertex(TM) Catheter
2025-08-29	K252364	Edwards Lifesciences	Edwards eSheath Optima introducer set