FDA.reportPublic FDA data

INTRODUCER SET

Primary DI
00850004162163
Brand
INTRODUCER SET
Company
VALFLUX GROUP, LLC
Model
VGHIS00
Catalog number
VGHIS00
Device description
VGHIS00 INTRODUCER SET
Published
2018-12-20
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180178000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004162163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004162163008500041621638500041621630850004162163

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+556230916442regulacao@valflux.com.br

Regulatory Flags#

DUNS number
050193715
Device count
1
Kit
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850004162217SELDINGER NEEDLEVGSN03VGSN032018-12-19
00850004162224SELDINGER NEEDLEVGSN03AVGSN03A2018-12-19
00850004162231SELDINGER NEEDLEVGSN06VGSN062018-12-19
00850004162125INTRODUCER SETVGCTR03VGCTR032018-12-20
00850004162132INTRODUCER SETVGCTR03AVGCTR03A2018-12-20
00850004162149INTRODUCER SETVGCTR04VGCTR042018-12-20
00850004162156INTRODUCER SETVGCTR04AVGCTR04A2018-12-20
00850004162170INTRODUCER SETVGHIS01VGHIS012018-12-20
00850004162187INTRODUCER SETVGHIS02VGHIS022018-12-20
00850004162194INTRODUCER SETVGHIS03VGHIS032018-12-20
00850004162200INTRODUCER SETVGHIS04VGHIS042018-12-20
00850004162248TRANSRADIAL PRESSURE BANDAGEVGPB04AVGPB04A2018-12-19
00850004162255TRANSRADIAL PRESSURE BANDAGEVGPB04BVGPB04B2018-12-19
00850004162019MANIFOLDVGAM0201VGAM02012018-12-19
00850004162026MANIFOLDVGAM0301VGAM03012018-12-19
00850004162033MANIFOLDVGAM0401VGAM04012018-12-19
00850004162040INFLATION DEVICEVGAI25CVGAI25C2018-12-19
00850004162057Y CONNECTOR KITVGYCK113FVGYCK113F2018-12-19
00850004162064HIGH PRESSURE TUBINGVGPMT0501VGPMT05012018-12-18
00850004162071HIGH PRESSURE TUBINGVGPMT0502VGPMT05022018-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450840610Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-20
00821329003455GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
00821329003462GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
00733132658855GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658862GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658879GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658886GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658893GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658909GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658916GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658923GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658930GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658947GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658954GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658961GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658978GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658985GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658992GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659005GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659012GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659029GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659036GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659043GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659050GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659067GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00850291007475Triever LA Transseptal SheathInari Medical, Inc.DYB2024-04-15
00810123710430ClotTriever SheathInari Medical, Inc.DYB2023-12-15
00733132629985GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2023-05-25
00733132628285GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2020-07-11
00733132628308GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2020-07-11