ThromboWire TWA

GUDID B251TWA1

The MegaVac Thrombectomy System is a single-use intravascular mechanical thrombectomy and aspiration system including a ThromboWire containing an embo

CAPTURE VASCULAR, INC.

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• Primary Device ID: B251TWA1
• NIH Device Record Key: 06e1f660-d6dd-4c47-a5da-61ad3bb5c51f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThromboWire
• Version Model Number: ATK
• Catalog Number: TWA
• Company DUNS: 080210058
• Company Name: CAPTURE VASCULAR, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B251TWA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040010

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2017-04-07

Devices Manufactured by CAPTURE VASCULAR, INC.

• B251TWA1 - ThromboWire: 2019-03-21The MegaVac Thrombectomy System is a single-use intravascular mechanical thrombectomy and aspiration system including a ThromboWire containing an embo
• B251TWA1 - ThromboWire: 2019-03-21 The MegaVac Thrombectomy System is a single-use intravascular mechanical thrombectomy and aspiration system including a ThromboW
• B251MCA1 - MegaVac Catheter: 2018-07-06 The MegaVac Thrombectomy System is a single-use intravascular mechanical thrombectomy and aspiration system including a ThromboW
• B251MTSA2 - MegaVac Mechanical Thrombectomy System: 2018-07-06 The MegaVac Thrombectomy System is a single-use intravascular mechanical thrombectomy and aspiration system including a ThromboW