FDA.report

ClariVein® IC

Primary DI
00884450429280
Brand
ClariVein® IC
Company
Merit Medical Systems, Inc.
Model
10884450429287
Catalog number
45-018-E2S/B
Published
2020-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KRACatheter, continuous flush

Product Code Classifications

CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions

SubmissionSupplement
K153502000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K153502000ClariVein ICVascular Insights, LLC2016-01-06KRA

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450429287PrimaryGS10
00884450429280Unit of UseGS10

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
184763290
Device count
5
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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