Scepter XC BC0411XC

GUDID 00810170018565

Balloon Catheter

MICROVENTION INC.

Intravascular occluding balloon catheter, image-guided
Primary Device ID00810170018565
NIH Device Record Key6f14bf17-5903-43a1-8224-f96971d0338a
Commercial Distribution StatusIn Commercial Distribution
Brand NameScepter XC
Version Model NumberBC0411XC-B
Catalog NumberBC0411XC
Company DUNS003263105
Company NameMICROVENTION INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100810170018565 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
Device Publish Date2016-09-24

On-Brand Devices [Scepter XC]

00810170018565Balloon Catheter
00810170016370Balloon Catheter
00842636020607Balloon Catheter
00842636020591Balloon Catheter

Trademark Results [Scepter XC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SCEPTER XC
SCEPTER XC
85201023 4305691 Live/Registered
MicroVention, Inc.
2010-12-17

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