Primary Device ID | M465ACX10106 |
NIH Device Record Key | 61062555-0d84-47fa-be89-953c527b60af |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Paxwire Occlusion Balloon System |
Version Model Number | ACX101 |
Catalog Number | ACX101 |
Company DUNS | 132286761 |
Company Name | Access Closure, 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 Size Text, specify | 0 |
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Device Issuing Agency | Device ID |
---|---|
HIBCC | M465ACX10106 [Primary] |
MJN | Catheter, Intravascular Occluding, Temporary |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2022-02-15 |
Device Publish Date | 2016-05-09 |
10862028000434 - MYNX CONTROL | 2022-02-15 Mynx Control VCD 6F 7F |
M465ACX10106 - Paxwire Occlusion Balloon System | 2022-02-15The PaxWire Balloon Occlusion System is indicated for temporary flow occlusion in the iliofemoral artery. |
M465ACX10106 - Paxwire Occlusion Balloon System | 2022-02-15 The PaxWire Balloon Occlusion System is indicated for temporary flow occlusion in the iliofemoral artery. |
M465MX50210 - MynxGrip Vascular Closure Device (5F) | 2022-02-15 MynxGrip Vascular Closure Device (5F) |
M465MX67210 - MynxGrip Vascular Closure Device (6F/7F) | 2022-02-15 MynxGrip Vascular Closure Device (6F/7F) |
M465MX67400 - Mynx Ace Vascular Closure Device (6F/7F) | 2022-02-15 Mynx Ace Vascular Closure Device (6F/7F) |
10862028000427 - MYNX CONTROL | 2020-07-21 Mynx Control VCD 5F |
20862028000400 - MYNXGRIP | 2020-04-17 MynxGrip 5F |
20862028000417 - MYNXGRIP | 2020-04-17 MynxGrip 6F/7F |