FDA.reportPublic FDA data

SMITHWICK Carotid Shunt

Primary DI
00858764006017
Brand
SMITHWICK Carotid Shunt
Company
Implantable Devices
Model
DB2000I
Catalog number
DB2000I
Device description
Carotid Shunt 9 Fr., dual balloon, 15 cm long, with safety balloon
Published
2016-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021608000SMITHWICK CAROTID SHUNTImplantable Devices2002-10-22DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858764006017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858764006017008587640060178587640060170858764006017

GMDN Terms#

Term, Definition table
TermDefinition
Carotid artery shuntA sterile device designed to serve as a temporary blood conduit (a shunt) connecting the distal internal carotid artery to the proximal common carotid artery allowing intravascular blood to continuously flow to the patient's brain during an endarterectomy procedure. It is typically designed as a hollow shaft with atraumatic dilations (e.g., balloons) on either end. The shaft is inserted into the lumen of the blood vessel, via a small incision at the surgical site. It is typically made of silicone elastomer and polyester radiopaque materials and is available in a range of diameters. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
727-526-9159implantabledevices@gmail.com

Regulatory Flags#

DUNS number
081364911
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858764006024SMITHWICK Carotid ShuntDWR1310BDWR1310B2016-10-24
00858764006031SMITHWICK Carotid ShuntDBD1009PTDBD1009PT2016-10-24
00858764006055SMITHWICK Carotid ShuntDB5000ITDB5000IT2016-10-24
00858764006062SMITHWICK Carotid ShuntDB1009PTDB1009PT2016-10-24
00858764006086SMITHWICK Carotid ShuntDWR1409NRSDWR1409NRS2016-10-24
00858764006109SMITHWICK Carotid ShuntLS1408LS14082016-10-24
00858764006116SMITHWICK Carotid ShuntSCS1014JSCS1014J2016-10-24
00858764006123SMITHWICK Carotid ShuntSCS1014JTSCS1014JT2016-10-24
00858764006130SMITHWICK Carotid ShuntSCS1209BTSCS1209BT2016-10-24
00858764006154SMITHWICK Carotid ShuntSDS1014JTSDS1014JT2016-10-24
00858764006161SMITHWICK Carotid ShuntSDS1209SDS12092016-10-24
00858764006178SMITHWICK Carotid ShuntSDS1209BTSDS1209BT2016-10-24
00858764006192SMITHWICK Carotid ShuntWR1310BWR1310B2016-10-24
00858764006215SMITHWICK Carotid ShuntWR1409NRSWR1409NRS2016-10-24
00858764006048SMITHWICK Carotid ShuntDBD1009PDBD1009P2016-10-24
00858764006079SMITHWICK Carotid ShuntDWR1409DWR14092016-10-24
00858764006208SMITHWICK Carotid ShuntWR1409WR14092016-10-24
00858764006000SMITHWICK Carotid ShuntDB1009PDB1009P2016-10-24
00858764006093SMITHWICK Carotid ShuntDWR1409SBDWR1409SB2016-10-24
00858764006147SMITHWICK Carotid ShuntSDS1014JSDS1014J2016-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776397180MillenniumAvalign Technologies, Inc.DXC2026-07-16
00190776395605MillenniumAvalign Technologies, Inc.DXC2026-07-14
00190776395698MillenniumAvalign Technologies, Inc.DXC2026-07-14
00190776395711MillenniumAvalign Technologies, Inc.DXC2026-07-14
00192896123557Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2026-07-10
00846159036152SCANLAN® Bulldog ClampSCANLAN INTERNATIONAL INCDXC2026-06-23
00846159036404SCANLAN® Bulldog ClampSCANLAN INTERNATIONAL INCDXC2026-06-09
00810220800348Adler Instrument CompanyAdler, Inc.DXC2026-06-02
10197344138890NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
08022057015884DeTACH Aortic Cross Clamp Head-LargeCORCYM SRLDXC2026-02-03
08022057015907DeTACH Aortic Cross Clamp Head-SmallCORCYM SRLDXC2026-02-03
10193489727173Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXC2022-08-04
10195594150808CARDINAL HEALTHCardinal Health 200, LLCDXC2021-07-09
20884521152134CovidienCardinal Health, Inc.DXC2016-09-24
M20630300D-Stat® Clamp topical hemostat accessoryVascular Solutions, Inc.DXC2016-09-15
M20635240Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635270Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635290Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635370Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
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10381780142997Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780143000Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780143017Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780143024Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
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