FDA.reportPublic FDA data

INTRODUCER SET

Primary DI
00850004162170
Brand
INTRODUCER SET
Company
VALFLUX GROUP, LLC
Model
VGHIS01
Catalog number
VGHIS01
Device description
VGHIS01 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
00850004162170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004162170008500041621708500041621700850004162170

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
00850004162163INTRODUCER SETVGHIS00VGHIS002018-12-20
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
10801902228700ARROWTELEFLEX INCORPORATEDDYB2026-09-22
10884450489809Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489816Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489823Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489830Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489847Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489854Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489861Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489878Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489885Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489892Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489908Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489915Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489922Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489939Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489946Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489953Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489960Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489977Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489984Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450495091Hydrophilic Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450510602Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510640Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510664Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10801902227109ARROWTELEFLEX INCORPORATEDDYB2026-09-03
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27