FDA.reportPublic FDA data

VSI Micro-Introducer Kit

Primary DI
M2067200V1
Brand
VSI Micro-Introducer Kit
Company
Vascular Solutions, Inc.
Model
7200V
Device description
VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inch or 0.038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
Published
2016-09-05
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101604000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101604000VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274VVascular Solutions, Inc.2011-01-24DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M2067200V1PackageHIBCC10In Commercial Distribution
M2067200V0PrimaryHIBCC0

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 Gauge5French
Needle Gauge21Gauge

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
008999906
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
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M20655680TrapLiner™ catheter55682017-02-07
M20655670TrapLiner™ catheter55672017-02-07
M20655690GuideLiner® V3 catheter55692016-09-05
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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