Aspire RX-LP6 Aspiration Catheter 136 ARX-LP6

GUDID B090ARXLP62

ASPIRE RX-LP6 Mechanical Thrombectomy System™ and the ASPIRE Mechanical Aspirator™ Drive Unit / Pump for removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

ZIEN MEDICAL TECHNOLOGIES, INC.

General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use
Primary Device IDB090ARXLP62
NIH Device Record Key7401fd76-daa3-455a-ae69-d3ec0299077b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAspire RX-LP6 Aspiration Catheter 136
Version Model NumberARX-LP6
Catalog NumberARX-LP6
Company DUNS017535668
Company NameZIEN MEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB090ARXLP60 [Primary]
HIBCCB090ARXLP61 [Package]
Contains: B090ARXLP60
Package: Shelf Carton [1 Units]
In Commercial Distribution
HIBCCB090ARXLP62 [Package]
Contains: B090ARXLP61
Package: Shipper [9 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXECatheter, Embolectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-09
Device Publish Date2017-08-17

Devices Manufactured by ZIEN MEDICAL TECHNOLOGIES, INC.

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