Esperance 3+ Aspiration Catheter System

GUDID 06970908213625

The Esperance® 3+ Aspiration Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter.

Shanghai Wallaby Medical Technologies Co., Inc.

Thrombectomy suction catheter
Primary Device ID06970908213625
NIH Device Record Key01b17e87-7e4f-4ebe-9af6-548a232df32d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsperance 3+ Aspiration Catheter System
Version Model NumberASP3F120KIT
Company DUNS544535295
Company NameShanghai Wallaby Medical Technologies Co., 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970908213625 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRYCatheter, Thrombus Retriever

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-19
Device Publish Date2024-11-11

On-Brand Devices [Esperance 3+ Aspiration Catheter System]

06970908213625The Esperance® 3+ Aspiration Catheter is a single-use, vascular catheter consisting of a single
06970908212932The Esperance® 3+ Aspiration Catheter is a single-use, vascular catheter consisting of a single
06970908212925The Esperance® 3+ Aspiration Catheter is a single-use, vascular catheter consisting of a single
06970908212918The Esperance® 3+ Aspiration Catheter is a single-use, vascular catheter consisting of a single
06970908212901The Esperance® 3+ Aspiration Catheter is a single-use, vascular catheter consisting of a single

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