FDA.reportPublic FDA data

PEROUSE MEDICAL

Primary DI
13661234027467
Brand
PEROUSE MEDICAL
Company
PEROUSE MEDICAL
Model
2015SPIMST
Catalog number
VPE2015SPIMST
Device description
POLYSITE ®Pressure injectable Implantable Infusion Port with silicone-filled suture holes
Published
2026-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
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
13661234027467PackageGS11In Commercial Distribution
03661234027460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1366123402746713661234027467
03661234027460036612340274603661234027460

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
267476323
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
03661234027453PEROUSE MEDICAL2015SPIVPE2015SPI2026-01-22
03661234027460PEROUSE MEDICAL2015SPIMSTVPE2015SPIMST2026-01-22
03661234027477PEROUSE MEDICAL3015SPIVPE3015SPI2026-01-22
03661234027484PEROUSE MEDICAL3015SPIMSTVPE3015SPIMST2026-01-22
13661234027450PEROUSE MEDICAL2015SPIVPE2015SPI2026-01-22
13661234027474PEROUSE MEDICAL3015SPIVPE3015SPI2026-01-22
13661234027481PEROUSE MEDICAL3015SPIMSTVPE3015SPIMST2026-01-22
03661234017430INFLATION SYSTEM03.804.413S2017-04-12
03661234026883PEROUSE MEDICAL03.804.413SVPE0252NB12025-10-15
03661234025213PEROUSE MEDICALE63101DPVPEE63101DP2024-11-11
33661234025214PEROUSE MEDICALE63101DPVPEE63101DP2024-11-11
03661234025206PEROUSE MEDICALE63101DNVPEE63101DN2024-04-09
33661234025207PEROUSE MEDICALE63101DNVPEE63101DN2024-04-09
03661234025190PEROUSE MEDICALE63101DMVPEE63101DM2024-03-26
03661234025237PEROUSE MEDICALE63101EAVPEE63101EA2024-03-26
43661234025198PEROUSE MEDICALE63101DMVPEE63101DM2024-03-26
43661234025235PEROUSE MEDICALE63101EAVPEE63101EA2024-03-26
03661234025183PEROUSE MEDICALE63101DLVPEE63101DL2024-03-20
03661234025220PEROUSE MEDICALE63101DRVPEE63101DR2024-03-20
03661234025244PEROUSE MEDICALE63101EBVPEE63101EB2024-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15051684018654BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018661BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018678BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018685BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018715BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018722BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018739BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018760BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018791XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018814XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018838XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018883XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018906XcelaAngiodynamics, Inc.LJT2024-09-20
15051684017978Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684017992Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018012Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018036Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018043Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018050Smart Port CTANGIODYNAMICS, INC.LJT2024-07-23
15051684018067Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018111Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018128Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018166Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018173Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018074Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018142Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018180Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018029Smart Port CTAngiodynamics, Inc.LJT2024-06-11
15051684018197Smart Port CTAngiodynamics, Inc.LJT2024-03-13
10801902189612ARROWTELEFLEX INCORPORATEDLJT2022-04-04