AcQRate Dx Fixed Curve Catheter 460650

GUDID 04260090928912

VascoMed GmbH

Cardiac mapping catheter, percutaneous, single-use
Primary Device ID04260090928912
NIH Device Record Key185f6102-208b-487a-ac52-6f5ce6099cb2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcQRate Dx Fixed Curve Catheter
Version Model Number5J 6F 5-5-5-280 mm
Catalog Number460650
Company DUNS322983446
Company NameVascoMed GmbH
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

Customer Support Contacts

Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS104260090928912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-01
Device Publish Date2021-10-22

On-Brand Devices [AcQRate Dx Fixed Curve Catheter]

0426009092896710J CS 6F 2-8-2 mm
0426009092895010J CS 6F 2-5-2 mm
0426009092894310J 6F 5 mm
0426009092893610J Sp 5F 2-8-2 mm
0426009092892910J Sp 5F 2-5-2 mm
042600909289125J 6F 5-5-5-280 mm
042600909289054M 6F 5 mm
042600909288994C 6F 5 mm Soft Tip
042600909288824C 6F 5 mm
042600909288754D 6F 5 mm
042600909288684J 6F 5 mm Soft Tip
042600909288514J 6F 5 mm
042600909287834 HIS 5F 5 mm
042600909287764C 5F 2-5-2 mm
042600909287694J Sp 5F 2-5-2 mm
042600909287524J Sp 100 cm 5F 2-5-2 mm
042600909287454J Sp 100 cm 5F 5 mm
042600909287384J Sp 5F 2 mm
042600909287214J Sp 4F 2-5-2 mm
042600909287144J Sp 4F 5 mm

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