Vascutek, Ltd. · Chrysalis Intelligence

Total clearances

2020-07-08 → 2025-02-27

Last 12 months

Product codes

Most recent

2025-02-27

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Class II	Cardiovascular	3	2025-02-27
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Class II	Cardiovascular	1	2020-07-08

Class III

PMA approvals (18)

Total PMA records

Originals + supplements

Distinct product codes

First decision

2022-04-19

Most recent

2026-06-24

Date	PMA #	Trade name	Type	Code	Device name	Specialty
2026-06-24	P210006-S019	Thoraflex Hybrid	30-Day Notice	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2026-04-20	P210006-S017	Thoraflex Hybrid	Real-Time Process	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2026-01-29	P210006-S016	Thoraflex Hybrid	Special (Immediate Track)	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2025-10-29	P210006-S015	Thoraflex Hybrid	30-Day Notice	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2025-10-16	P210006-S014	Thoraflex Hybrid	30-Day Notice	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2025-07-30	P210006-S013	Thoraflex Hybrid	30-Day Notice	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2025-04-09	P210006-S012	Thoraflex Hybrid	30-Day Notice	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2025-03-28	P210006-S010	Thoraflex Hybrid	Normal 180 Day Track	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2025-01-27	P210006-S011	Thoraflex Hybrid	30-Day Notice	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2024-08-01	P210006-S009	Thoraflex Hybrid	Normal 180 Day Track No User Fee	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2024-01-11	P210006-S007	Thoraflex Hybrid	30-Day Notice	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2023-11-20	P210006-S005	Thoraflex Hybrid	135 Review Track For 30-Day Notice	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2023-09-21	P210006-S006	Thoraflex Hybrid	30-Day Notice	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2023-05-26	P210006-S004	Thoraflex Hybrid	30-Day Notice	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2022-09-29	P210006-S003	Thoraflex Hybrid	Real-Time Process	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2022-08-08	P210006-S001	Thoraflex Hybrid	Normal 180 Day Track No User Fee	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2022-06-16	P210006-S002	Thoraflex Hybrid	30-Day Notice	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown
2022-04-19	P210006	Thoraflex Hybrid	Original	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown

Safety

Recalls (3)

Class I (serious)

Risk of injury / death

Total recalls

Currently ongoing

Most recent

2025-12-18

Date	Severity	Status	Recall #	Product	Code	Reason
2025-12-18	Class II	Ongoing	Z-1492-2026	Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 6…	—	Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry …
2021-07-08	Class II	Terminated	Z-2543-2021	The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Pat…	—	The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
2021-07-08	Class II	Terminated	Z-2542-2021	The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Strai…	—	The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

Filings

All 510(k) clearances (4)

Date	K-number	Device	Code	Class	Specialty
2025-02-27	K241550	Gelweave Vascular Prostheses	DSY	Class II	Cardiovascular
2024-11-15	K241070	Gelsoft Plus Vascular Prostheses	DSY	Class II	Cardiovascular
2021-04-06	K202703	Vascutek Gelsoft Plus ERS Vascular Graft	DSY	Class II	Cardiovascular
2020-07-08	K200955	Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch	DXZ	Class II	Cardiovascular