ClariVein® IC

Primary DI
30854339004021
Brand
ClariVein® IC
Company
VASCULAR INSIGHTS, LLC
Model
65-018-E4S
Catalog number
65-018-E4S
Device description
ClariVein® IC is a specialty infusion cathether with 360 degree rotatable fluid dispersion wire connected to a proximally located integral battery motor drive unit (MDU). The MDU includes the speed selector, handle grip and syringe support features to facilitate physician-controlled infusion of the selected agent. The ClariVein® IC is introduced through a microintroducer. Utilizing vascular imaging, the coaxial catheter sheath with dispersion wire is navigated through the vasculature to the treatment site. Fluid delivered through the catheter assembly's infusion port, surrounds the dispersion wire and exits via an opening at the distal end of the catheter. The ClariVein® IC has no user serviceable parts or capital equipment. It is fully disposable. "
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRACatheter, Continuous Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071468000CLARIVEIN CATHETERVascular Insights, LLC2008-03-20KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30854339004021PackageGS15In Commercial Distribution
10854339004027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085433900402130854339004021
1085433900402710854339004027

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular infusion catheterA sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature; some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor microcatheter for access into superselective small vessels. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length65Centimeter
Outer Diameter0.0345Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
203-446-5711info@vascularinsights.com

Regulatory Flags#

DUNS number
969986236
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10854339004010ClariVein® IC45-018-E2S45-018-E2S2016-09-19
10854339004027ClariVein® IC65-018-E4S65-018-E4S2016-09-19
10854339004034ClariVein® IC85-018-E140S85-018-E140S2016-09-19
10854339004041ClariVein® ICDEMO-45-018-E2SDEMO-45-018-E2S2016-09-19
30854339004014ClariVein® IC45-018-E2S45-018-E2S2016-09-19
30854339004038ClariVein® IC85-018-E140S85-018-E140S2016-09-19
30854339004045ClariVein® ICDEMO-45-018-E2SDEMO-45-018-E2S2016-09-19

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