CAPTURE VASCULAR, INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Catheter, Embolectomy (DXE) (3)

Premarket Exempt

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MegaVac Catheter - B251MCA1 Catalog Number : MCA

Device Description : The MegaVac Thrombectomy System is a single-use intravascular mechanical thrombe 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 Class : 2

Duns Number: 080210058

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

MegaVac Mechanical Thrombectomy System - B251MTSA2 Catalog Number : MTSA

Device Class : 2

Duns Number: 080210058

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

ThromboWire - B251TWA1 Catalog Number : TWA

Device Class : 2

Duns Number: 080210058

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

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