Access Closure, Inc.

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Filters

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

Device, hemostasis, vascular (MGB) (4) Device, Hemostasis, Vascular (MGB) (3) Catheter, Intravascular Occluding, Temporary (MJN) (1)

Premarket Exempt

Clear

MYNXGRIP - 10862028000403 Catalog Number : MX5021

Device Description : MynxGrip 5F

Device Class : 3

Duns Number: 132286761

Premarket Exempt : No

Product Code : MGB

Prescription Use : Yes

Device Count : 1

MYNXGRIP - 10862028000410 Catalog Number : MX6721

Device Description : MynxGrip 6F/7F

Device Class : 3

Duns Number: 132286761

Premarket Exempt : No

Product Code : MGB

Prescription Use : Yes

Device Count : 1

MYNX CONTROL - 10862028000427 Catalog Number : MX5060

Device Description : Mynx Control VCD 5F

Device Class :

Duns Number: 132286761

Premarket Exempt : No

Product Code : MGB

Prescription Use : Yes

Device Count : 1

MYNX CONTROL - 10862028000434 Catalog Number : MX6760

Device Description : Mynx Control VCD 6F 7F

Device Class :

Duns Number: 132286761

Premarket Exempt : No

Product Code : MGB

Prescription Use : Yes

Device Count : 1

Paxwire Occlusion Balloon System - M465ACX10106 Catalog Number : ACX101

Device Description : The PaxWire Balloon Occlusion System is indicated for temporary flow occlusion i The PaxWire Balloon Occlusion System is indicated for temporary flow occlusion in the iliofemoral artery.

Device Class : 2

Duns Number: 132286761

Premarket Exempt : No

Product Code : MJN

Prescription Use : Yes

Device Count : 1

MynxGrip Vascular Closure Device (5F) - M465MX50210 Catalog Number : MX5021

Device Description : MynxGrip Vascular Closure Device (5F)

Device Class :

Duns Number: 132286761

Premarket Exempt : No

Product Code : MGB

Prescription Use : Yes

Device Count : 1

MynxGrip Vascular Closure Device (6F/7F) - M465MX67210 Catalog Number : MX6721

Device Description : MynxGrip Vascular Closure Device (6F/7F)

Device Class :

Duns Number: 132286761

Premarket Exempt : No

Product Code : MGB

Prescription Use : Yes

Device Count : 1

Mynx Ace Vascular Closure Device (6F/7F) - M465MX67400 Catalog Number : MX6740

Device Description : Mynx Ace Vascular Closure Device (6F/7F)

Device Class :

Duns Number: 132286761

Premarket Exempt : No

Product Code : MGB

Prescription Use : Yes

Device Count : 1

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