FDA.reportPublic FDA data

Minnie® support catheter

Primary DI
M20657050
Brand
Minnie® support catheter
Company
Vascular Solutions, Inc.
Model
5705
Device description
The Minnie support catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the arterial and/or coronary vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices. The Minnie support catheters also may be used to subselectively infuse/deliver therapeutic agents.
Published
2016-09-05
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082337000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082337000MINNIE SUPPORT CATHETERVascular Solutions, Inc.2009-01-15DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M20657050PrimaryHIBCC0

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
Device Size Text, specify0
Device Size Text, specify0
Length65Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-240-6001customerservice@vasc.com

Regulatory Flags#

DUNS number
008999906
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M20679600VSI StraitSet™ micro-introducer kit79602018-08-09
M20679610VSI StraitSet™ micro-introducer kit79612018-08-09
M20679620VSI StraitSet™ micro-introducer kit79602018-08-09
M20679640VSI StraitSet™ micro-introducer kit79602018-08-09
M20679650VSI StraitSet™ micro-introducer kit79612018-08-09
M20679710VSI StraitSet™ micro-introducer kit79612018-08-09
M206780500SmartNeedle® vascular access system780502016-09-06
M206780600SmartNeedle® vascular access system780602016-09-06
M206780300SmartNeedle® vascular access system780302016-09-05
M206780400SmartNeedle® vascular access system780402016-09-06
M206720000SmartNeedle® monitor720002016-09-23
M20631010Thrombix® Hemostasis Patch topical hemostat31012016-09-15
M20630100D-Stat® 2 Dry topical hemostat30102016-09-15
M20681500Teirstein Edge™ device organizer81502016-09-05
M20681510Angio Assist™ docking station81512016-09-05
M20673710Axis™ guidewire73712016-09-05
M20673720Axis™ guidewire73722016-09-05
M20674720VSI Tru-Torque™ guidewire74722016-09-05
M20674730VSI Tru-Torque™ guidewire74732016-09-05
M20674790Amplatz SST™ guidewire74792016-09-05

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