FDA.reportPublic FDA data

VSI StraitSet™ micro-introducer kit

Primary DI
M20679650
Brand
VSI StraitSet™ micro-introducer kit
Company
Vascular Solutions, Inc.
Model
7961
Published
2018-08-09
Public version status
Update
Distribution status
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
DREDilator, Vessel, For Percutaneous Catheterization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071330000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071330000GALTSTICK INTRODUCER SYSTEMGalt Medical Corp.2007-10-31DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M20679650PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French
Length20Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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M20655670TrapLiner™ catheter55672017-02-07
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M20655700GuideLiner® V3 catheter55702016-09-05
M20655710GuideLiner® V3 catheter55712016-09-05
M20655720GuideLiner® V3 catheter55722016-09-05
M20655730GuideLiner® V3 catheter55732016-09-05
M20656210Turnpike® Gold catheter56212016-09-05
M20656220Turnpike® Gold catheter56222016-09-05
M20656380Turnpike® LP catheter56382016-09-05
M20656390Turnpike® LP catheter56392016-09-05
M20656400Turnpike® Spiral catheter56402016-09-05
M20656410Turnpike® Spiral catheter56412016-09-05
M20656420Turnpike® catheter56422016-09-05
M20656430Turnpike® catheter56432016-09-05
M20654700GuideLiner® Navigation™ catheter54702016-09-05
M20654710GuideLiner® Navigation™ catheter54712016-09-05
M20654720GuideLiner® Navigation™ catheter54722016-09-05
M20654730GuideLiner® Navigation™ catheter54732016-09-05

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