FDA.report

VYGON

Primary DI
00849884007459
Brand
VYGON
Company
Vygon Corporation
Model
3015SPI
Catalog number
3015SPI
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

Related Records

Product Codes

CodeName
LJTPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
LJTPort & Catheter, Implanted, Subcutaneous, IntravascularGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K122834000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K122834000POLYSITE IMPLANTABLE INFUSION PORTSPerouse Medical2013-12-11LJT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20849884007453PackageGS11In Commercial Distribution
30849884007450PackageGS130In Commercial Distribution
00849884007459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2084988400745320849884007453
3084988400745030849884007450
00849884007459008498840074598498840074590849884007459

GMDN Terms

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 DIBrandModelCatalogPublished
00849884007435VYGON2015SPI2015SPI2026-05-22
00849884007442VYGON2015SPIMST2015SPIMST2026-05-22
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 DIBrandCompanyProduct codePublished
00849884007435VYGONVygon CorporationLJT2026-05-22
00849884007442VYGONVygon CorporationLJT2026-05-22
00849884007466VYGONVygon CorporationLJT2026-05-22
13661234027450PEROUSE MEDICALPEROUSE MEDICALLJT2026-01-22
13661234027467PEROUSE MEDICALPEROUSE MEDICALLJT2026-01-22
13661234027474PEROUSE MEDICALPEROUSE MEDICALLJT2026-01-22
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