Question 1

What types of medical devices does Walk Vascular LLC manufacture?

Accepted Answer

Walk Vascular LLC specializes in vascular medical devices, primarily thrombectomy suction catheters used to remove clots during procedures like thrombectomies. Their product line also includes single-use suction and irrigation tubing, as well as surgical irrigation/aspiration tubing sets. These devices support minimally invasive cardiovascular interventions, where precise fluid control and clot removal are critical.

Question 2

Where is Walk Vascular LLC based?

Accepted Answer

Walk Vascular LLC is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.

Question 3

Which regulatory registries list Walk Vascular LLC’s devices?

Accepted Answer

Walk Vascular LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II devices, which include their thrombectomy catheters, suction/irrigation tubing, and tubing sets. Listing in the UDI database is a requirement for Class II devices in the U.S.

Question 4

How are Walk Vascular LLC’s devices classified under FDA regulations?

Accepted Answer

All of Walk Vascular LLC’s devices fall under FDA’s Class II classification. This classification applies to products that pose moderate risk and require special controls—such as performance standards, post-market surveillance, or labeling requirements—to ensure safety and effectiveness. Thrombectomy catheters and irrigation tubing are typically classified as Class II due to their role in critical vascular procedures.

Device	Model / Reference	Registries	Class	Status
JETi	WV088F	FDA UDI	Class II	Active
JETi Peripheral Catheter	WV6120-OUS	FDA UDI	Class II	Unknown
JETi Thrombectomy System, Sterile Disposable Components Kit, 8 Fr	WV8803	FDA UDI	N/A	Unknown
JETi	WV062F	FDA UDI	Class II	Active
JETi Saline Drive Unit	WV0340	FDA UDI	Class II	Unknown
JETi All In One Sterile Kit - 6Fr	WV6203A	FDA UDI	N/A	Unknown
JETi Accessory Cart Attachment Kit	WV0016-1	FDA UDI	Class II	Unknown
ClearLumen II Pump Set	WV06PS01	FDA UDI	Class II	Unknown
JETi Pump Set	WV-JSET-1	FDA UDI	Class II	Unknown
JETi All In One Sterile Kit - 8Fr	WV8803A	FDA UDI	N/A	Unknown
ClearLumen Peripheral Saline Drive Unit	WVSDU0102	FDA UDI	Class II	Unknown
JETi Peripheral Catheter	WV0006-01	FDA UDI	Class II	Unknown
JETi Sterile Tubing Kit, 6 Fr	WVTUBE-6AU	FDA UDI	N/A	Unknown
JETi Peripheral Catheter	WV088F-1	FDA UDI	Class II	Unknown
JETi	WVHAND	FDA UDI	Class II	Active
JETi Thrombectomy System, Sterile Disposable Components Kit	WV6003	FDA UDI	N/A	Unknown
JETi Thrombectomy System, Sterile Disposable Components Kit, 8Fr	WV8003-1	FDA UDI	Class II	Unknown
JETi Sterile Tubing Kit	WVTUBE-6	FDA UDI	N/A	Unknown
JETi Peripheral Catheter	WV008F-1	FDA UDI	Class II	Unknown
JETi All In One Non-Sterile Kit	WV1500A	FDA UDI	Class II	Unknown
JETi Peripheral Catheter	WV008F	FDA UDI	Class II	Unknown
JETi Sterile Tubing Kit	WVTUBE-8	FDA UDI	Class II	Unknown
JETi Sterile Tubing Kit	WVTUBE-8AU	FDA UDI	N/A	Unknown
JETi Saline Drive Unit	WV0340-1	FDA UDI	Class II	Unknown
JETi Peripheral Catheter	WV8100	FDA UDI	Class II	Unknown
JETi All In One Accessory Cart	WVCART	FDA UDI	Class II	Unknown
JETi Saline Drive Unit	WV0345-1	FDA UDI	Class II	Unknown
JETi Pump Set	WV0010	FDA UDI	Class II	Unknown
JETi Thrombectomy System, Sterile Disposable Components Kit	WV6003-1	FDA UDI	N/A	Unknown
JETi Thrombectomy System, Sterile Disposable Components Kit, 8 Fr	WV8803-1	FDA UDI	N/A	Unknown
JETi Thrombectomy System, Sterile Disposable Components Kit, 8Fr	WV8003	FDA UDI	Class II	Unknown
JETi Peripheral Catheter	WV0006-01	FDA UDI	Class II	Unknown
ClearLumen II Peripheral Catheter	WV0613507-04	FDA UDI	Class II	Unknown
JETi All In One Saline Drive Unit	WVSDUP	FDA UDI	Class II	Unknown
JETi Thrombectomy System, Sterile Disposable Components Kit, 6 Fr	WV6203	FDA UDI	N/A	Unknown
JETi	WV-JSET	FDA UDI	Class II	Active
JETi Saline Drive Unit	WV0345	FDA UDI	Class II	Unknown
JETi Saline Drive Unit	WV0008	FDA UDI	Class II	Unknown
JETi Peripheral Catheter	WV062F-1	FDA UDI	Class II	Unknown
JETi Non-Sterile Disposable Accessory Device	WV1500	FDA UDI	Class II	Unknown
JETi Thrombectomy System, Sterile Disposable Components Kit, 6 Fr	WV6203-1	FDA UDI	N/A	Unknown
JETi Accessory Cart Attachment Kit	WV0016	FDA UDI	Class II	Unknown
JETi All In One Accessory Kit	WVTUB1	FDA UDI	Class II	Unknown
JETi Saline Drive Unit	WV0007	FDA UDI	Class II	Unknown
JETi Peripheral Catheter	WV6120-US	FDA UDI	Class II	Unknown
JETi Peripheral Catheter	WV6120	FDA UDI	Class II	Unknown
ClearLumen II Pump Set	WV06PS02	FDA UDI	Class II	Unknown
JETi Pump Set	WV0009	FDA UDI	Class II	Unknown

WALK VASCULAR L.L.C.

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