FDA.reportPublic FDA data

Smart Port CT

Primary DI
15051684018197
Brand
Smart Port CT
Company
Angiodynamics, Inc.
Model
H787CT96STSDVI1
Catalog number
CT96STSD-VI
Device description
Smart Port CT Single Titanium Port System with Attachable 9.6F x 66cm Silicone Catheter and 10 F Introducer Kit (with Valved Introducer)
Published
2024-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular
LJTPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062414000VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SETRita Medical Systems, Inc.2007-02-01LJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H787CT96STSDVI1PreviousHIBCC0
15051684018197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168401819715051684018197

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge9.6French
Length66Centimeter
Lumen/Inner Diameter1.6Millimeter
Outer Diameter3.2Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(800)772-6446customerservice@angiodynamics.com

Regulatory Flags#

DUNS number
079252781
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15051684023801Uni-Fuse+H787124018450124018452024-08-01
15051684023825Uni-Fuse+H787124018480124018482024-08-01
15051684023832Uni-Fuse+H787124018490124018492024-08-01
15051684023849Uni-Fuse+H787124018510124018512024-08-01
15051684023863Uni-Fuse+H787124018540124018542024-08-01
15051684023870Uni-Fuse+H787124018550124018552024-08-01
15051684023887Uni-Fuse+H787124018570124018572024-08-01
15051684023894Uni-Fuse+H787124018580124018582024-08-01
15051684023900Uni-Fuse+H787124018590124018592024-08-01
15051684023924Uni-Fuse+H787124018610124018612024-08-01
15051684023931Uni-Fuse+H787124018620124018622024-08-01
15051684023948Uni-Fuse+H787124018630124018632024-08-01
15051684030069NanoKnifeH78720300351US020300351US2026-05-04
15051684013727NanoKnifeH78720300301US020300301US2026-04-30
15051684017930NanoKnifeH787204001090204001092026-04-30
15051684017947NanoKnifeH787204001100204001102026-04-30
15051684017954NanoKnifeH787204003010204003012026-04-30
15051684029643NanoKnifeH787204001110204001112026-04-30
H787204001110NanoKnife204001112022-10-07
H787204003010NanoKnife204003012016-09-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840006535VYGONVygon CorporationFPA2020-03-12
07640110985465Tita Jet Light PFM MEDICAL INCORPORATEDLJT2020-02-27
07640110985472Tita Jet LightPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110985489Jet Port PlusPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110985496T-Port PFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987247T-PortPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987254T-PortPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987476T-PortPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987506Jet Port PlusPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987513Tita Jet LightPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987537T-Port PFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987643Jet Port PlusPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987704Low Profile PeripheralPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987728Low Profile PeripheralPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987742Low Profile PeripheralPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987940Jet Port Plus IIPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987988Tita Jet Light IIPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110988336T-PortPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110988350T-PortPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110988374T-Port PFM MEDICAL INCORPORATEDLJT2020-02-27
07640110988398T-Port PFM MEDICAL INCORPORATEDLJT2020-02-27
07640110988411T-PortPFM MEDICAL INCORPORATEDLJT2020-02-27