ThromboWire

Basic Information

• Brand Name: ThromboWire
• Primary DI: B251TWA1
• Version / Model: ATK
• Catalog Number: TWA
• Company Name: CAPTURE VASCULAR, INC.
• Labeler DUNS: 080210058
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-07
• Public Version: 6
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 06e1f660-d6dd-4c47-a5da-61ad3bb5c51f

Device Description

The MegaVac Thrombectomy System is a single-use intravascular mechanical thrombectomy and aspiration system including a ThromboWire containing an embolectomy element. The MegaVac Catheter’s SafeSealTM technology utilizes a distal silicone coated nitinol braid that expands to temporarily occlude antegrade blood flow. The catheter body has inner and outer coaxial shafts that expand the braid, temporarily occluding the vessel and allowing for aspiration. The proximal handle assembly actuates the SafeSeal funnel. The ThromboWire consists of a nitinol embolectomy element that when expanded by the proximal actuation handle, can serve to pull matter towards the MegaVac catheter.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXE	Catheter, Embolectomy	Cardiovascular	870.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61779	Thrombectomy wire-net	A device intended to be percutaneously introduced into the vasculature (coronary, peripheral and/or intracranial) through an appropriate intravascular catheter for the removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction; revascularization may also be achieved through thrombus reorientation. Also referred to as a stent retriever or clot retrieval catheter, it consists of an expanding, stent-like wire net connected to a pusher wire primarily intended to grip and remove the emboli/thrombi; it might include a guide-catheter dedicated to introduction of the wire-net. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B251TWA1	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K040010	000