WavelinQ WQ4300

GUDID 00801741189104

WavelinQ™ EndoAVF System

CLEARSTREAM TECHNOLOGIES LIMITED

Vascular guide-catheter, single-use
Primary Device ID00801741189104
NIH Device Record Keyd532acac-5aa2-4c5c-bce1-d0fa0b08dc55
Commercial Distribution StatusIn Commercial Distribution
Brand NameWavelinQ
Version Model NumberWQ4300
Catalog NumberWQ4300
Company DUNS989214291
Company NameCLEARSTREAM TECHNOLOGIES LIMITED
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com

Device Dimensions

Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge4 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741189104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PQKPercutaneous catheter for creation of an arteriovenous fistula for hemodialysis access

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-12
Device Publish Date2019-11-15

On-Brand Devices [WavelinQ]

00801741189104WavelinQ™ EndoAVF System
00801741218033WavelinQ Generator

Trademark Results [WavelinQ]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WAVELINQ
WAVELINQ
88021599 not registered Live/Pending
C. R. BARD, INC.
2018-06-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.