DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Device class

Class II

Regulation 870.3450

Total clearances

2020-12-11 → 2026-04-27

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.3450

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
W. L. Gore & Associates, Inc.	4	0	2024-03-01
Vascutek, Ltd.	3	0	2025-02-27
Peca Labs	3	0	2024-01-17
Merit Medical Systems, Inc.	2	0	2022-08-15
Atrium Medical Corporation	1	0	2024-03-28
Maquet Cardiovascular, LLC	1	1	2026-04-27
Vascular Flow Technologies Limited	1	1	2025-10-20

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
35521	CPT	—	High	Standard CPT for vascular graft placement ≥6mm diameter
C9356	HCPCS	Tendon, porous matrix of cross-linked collagen and glycosaminoglycan matrix (tenoglide tendon protector sheet), per square centimeter ✓ CMS-verified description	Medium	Vascular graft or conduit supply code alternative

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-04-27	K252445	Maquet Cardiovascular, LLC	Fusion Bioline Vascular Graft
2025-10-20	K252277	Vascular Flow Technologies Limited	Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)
2025-02-27	K241550	Vascutek, Ltd.	Gelweave Vascular Prostheses
2024-11-15	K241070	Vascutek, Ltd.	Gelsoft Plus Vascular Prostheses
2024-03-28	K231972	Atrium Medical Corporation	Advanta VXT Vascular Graft, Flixene Vascular Graft
2024-03-01	K240083	W. L. Gore & Associates, Inc.	GORE® PROPATEN® Vascular Graft
2024-01-17	K233783	Peca Labs, Inc.	exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
2024-01-09	K232312	W. L. Gore & Associates, Inc.	GORE® PROPATEN® Vascular Graft
2023-12-19	K233551	W. L. Gore & Associates, Inc.	GORE® ACUSEAL Vascular Graft
2023-06-23	K231505	W. L. Gore & Associates, Inc.	GORE® ACUSEAL Vascular Graft
2022-08-15	K213845	Merit Medical Systems, Inc.	HeRO Graft
2022-08-04	K221628	Peca Labs	exGraft, exGraft Carbon
2021-05-25	K203724	Merit Medical Systems, Inc.	HeRO Graft, HeRO Adapter
2021-04-06	K202703	Vascutek, Ltd.	Vascutek Gelsoft Plus ERS Vascular Graft
2020-12-11	K202471	Peca Labs	exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft