FDA.reportPublic FDA data

BioFlo Vortex

Primary DI
15051684017220
Brand
BioFlo Vortex
Company
Angiodynamics, Inc.
Model
H787CT80LPPANFVI0
Catalog number
CT80LPPANFVI
Device description
SmartPort Plastic Low Profile Port with Vortex Technology
Published
2024-11-19
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
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
K190559000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190559000SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.2020-05-22LJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H787CT80LPPANFVI0PrimaryHIBCC0
15051684017220SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168401722015051684017220

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 Gauge8French
Length63Centimeter
Outer Diameter2.6Millimeter
Pressure300Pound per Square Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com
+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
15051684018777BioFloH96544027044-0272024-09-20
15051684018784BioFloH96544028044-0282024-09-20
05051684018473LifeportH787LPS30040LPS30042026-06-23
05051684018480LifeportH787LPS30050LPS30052026-06-23
05051684018497LifeportH787LPS30060LPS30062026-06-23
05051684018503LifeportH787LPS30070LPS30072026-06-23
05051684018510LifeportH787LPS30080LPS30082026-06-23
05051684018527LifeportH787LPS30090LPS30092026-06-23
05051684018534LifeportH787LPS30170LPS30172026-06-23
05051684018541LifeportH787LPS30230LPS30232026-06-23
05051684018558LifeportH787LPS30250LPS30252026-06-23
05051684018565LifeguardH787LG191000LG-19-1002026-06-23
05051684018572LifeguardH787LG19750LG-19-752026-06-23
05051684018589LifeguardH787LG201000LG-20-1002026-06-23
05051684018596LifeguardH787LG201500LG-20-1502026-06-23
05051684018602LifeguardH787LG20500LG-20-502026-06-23
05051684018619LifeguardH787LG20750LG-20-752026-06-23
05051684018626LifeguardH787LG221000LG-22-1002026-06-23
05051684018633LifeguardH787LG22500LG-22-502026-06-23
05051684018640LifeguardH787LG22750LG-22-752026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014030802FLEXI-PORTPortal Access, Inc.LJT2026-07-05
00860014030819FLEXI-PORTPortal Access, Inc.LJT2026-07-05
00860014030833FLEXI-PORTPortal Access, Inc.LJT2026-07-05
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
15051684018777BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018784BioFloAngiodynamics, 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