FDA.reportPublic FDA data

VYGON

Primary DI
00849884007442
Brand
VYGON
Company
Vygon Corporation
Model
2015SPIMST
Catalog number
2015SPIMST
Device description
POLYSITE ®Pressure injectable Implantable Infusion Port with silicone-filled suture holes
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LJTPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJTPort & Catheter, Implanted, Subcutaneous, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122834000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122834000POLYSITE IMPLANTABLE INFUSION PORTSPerouse Medical2013-12-11LJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20849884007446PackageGS11In Commercial Distribution
30849884007443PackageGS130In Commercial Distribution
00849884007442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084988400744620849884007446
3084988400744330849884007443
00849884007442008498840074428498840074420849884007442

GMDN Terms#

Term, Definition table
TermDefinition
Vascular port/catheterA fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.

Regulatory Flags#

DUNS number
120818216
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
00849884007435VYGON2015SPI2015SPI2026-05-22
00849884007459VYGON3015SPI3015SPI2026-05-22
00849884007466VYGON3015SPIMST3015SPIMST2026-05-22
00849884007510VYGONVYML4S3001A-1VYML4S3001A-12026-05-22
00849884007527VYGONVYML5D3003AVYML5D3003A2026-05-22
00849884007541VYGONVIS-1045VIS-10452026-05-22
00849884007558VYGONVIS-1055VIS-10552026-05-22
30849884007474VYGONAMS-7170CPAMS-7170CP2026-03-06
30849884007320VYGONAMS-8070CP AMS-8070CP 2026-02-11
30849884007313VYGONVYLFMM1004 VYLFMM1004 2026-01-23
50849884007300VYGONVYLFMM1003VYLFMM10032026-01-22
30849884007122VYGONVYPL5T1003-1 VYPL5T1003-1 2025-11-20
30849884007146VYGONVYPL4S1001LW-1VYPL4S1001LW-12025-11-20
30849884007030VYGONVYML3S1003-1 VYML3S1003-1 2025-09-26
30849884007078VYGONVYPL3S1003-1VYPL3S1003-12025-09-26
30849884007214VYGONAMS-9777CPAMS-9777CP2025-09-26
30849884007047VYGONVYML4D1003-1 VYML4D1003-1 2025-09-25
30849884007085VYGONVYPL4D1003-1 VYPL4D1003-1 2025-09-25
30849884007207VYGONAMS-2087CPAMS-2087CP2025-09-25
30849884007191VYGONAMS-2008AMS-20082025-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849884007435VYGONVygon CorporationLJT2026-05-22
00849884007459VYGONVygon CorporationLJT2026-05-22
00849884007466VYGONVygon CorporationLJT2026-05-22
13661234027450PEROUSE MEDICALPEROUSE MEDICALLJT2026-01-22
13661234027467PEROUSE MEDICALPEROUSE MEDICALLJT2026-01-22
13661234027474PEROUSE MEDICALPEROUSE MEDICALLJT2026-01-22
13661234027481PEROUSE MEDICALPEROUSE MEDICALLJT2026-01-22
10610586032660ICU Medical, Inc.ICU MEDICAL, INC.LJT2026-01-05
10801741232401AllPoints Port Access System PowerLocBard Access Systems, Inc.LJT2024-12-05
30801741232429AllPoints Port Access System PowerLocBard Access Systems, Inc.LJT2024-12-05
15051684016858BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
15051684016865BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
15051684018692BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018708BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018746BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018753BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018777BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018784BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018807XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018821XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018845XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018852XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018869XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018876XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018890XcelaAngiodynamics, Inc.LJT2024-09-20
15051684017985Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018005Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018081Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018098Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018104Smart Port CTAngiodynamics, Inc.LJT2024-07-23