FDA.reportPublic FDA data

AngioDynamics

Primary DI
H787065200010
Brand
AngioDynamics
Company
ANGIODYNAMICS, INC.
Model
06520001
Device description
Straight, Non-Coring, High-Flow Needle
Published
2016-09-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQRCANNULA, CATHETER
DQXWIRE, GUIDE, CATHETER
DRCTrocar
DYBINTRODUCER, CATHETER
FMINeedle, hypodermic, single lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQRCannula, CatheterCardiovascular2
DQXWire, Guide, CatheterCardiovascular2
DRCTrocarCardiovascular2
DYBIntroducer, CatheterCardiovascular2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051655000
K961088000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051655000ANGIODYNAMICS, INC., MICRO ACCESS KITSAngioDynamics, Inc.2005-09-12DQR
K961088000NON-CORING NEEDLEArrow Intl., Inc.1996-07-02FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H787065200015PackageHIBCC10Not in Commercial Distribution
H787065200010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular port administration setA collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags#

DUNS number
079105071
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H787140650Syntrax Support Catheter14-0652021-11-02
H787140900Syntrax Support Catheter14-0902021-11-02
H787141350Syntrax Support Catheter14-1352021-11-02
H787141500Syntrax Support Catheter14-1502021-11-02
H787141800Syntrax Support Catheter14-1802021-11-02
H787180650Syntrax Support Catheter18-0652021-11-02
H787180900Syntrax Support Catheter18-0902021-11-02
H787181350Syntrax Support Catheter18-1352021-11-02
H787181500Syntrax Support Catheter18-1502021-11-02
H787181800Syntrax Support Catheter18-1802021-12-16
H787350650Syntrax Support Catheter35-0652021-11-02
H787350900Syntrax Support Catheter35-0902021-11-02
H787351350Syntrax Support Catheter35-1352021-11-02
H787351500Syntrax Support Catheter35-1502021-11-02
H787351801Syntrax Support Catheter35-1802021-11-02
15051684018777BioFloH96544027044-0272024-09-20
15051684018784BioFloH96544028044-0282024-09-20
05051684018473LifeportH787LPS30040LPS30042026-06-23
05051684018480LifeportH787LPS30050LPS30052026-06-23
05051684018497LifeportH787LPS30060LPS30062026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972857295677contour comfort Pen NeedleSandstone Medical (Suzhou) Inc.FMI2026-08-19
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DYB2026-07-15
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00685447005285TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005292TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005308TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005315TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005322TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005339TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005346TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005353TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005360TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005377TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005384TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005391TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005407TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005414TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005421TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005438TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005445TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
10801902190519ARROWTELEFLEX INCORPORATEDDYB2021-09-02
00389701012353R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012360R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012377R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012384R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00685447004691ExpanSure Large Access Transseptal DilatorBaylis Médicale Cie IncDYB2019-10-23
00685447004707ExpanSure Large Access Transseptal DilatorBaylis Médicale Cie IncDYB2019-10-23
00685447004646VersaCross Steerable SheathBaylis Médicale Cie IncDYB2019-09-23
00685447004653VersaCross Steerable SheathBaylis Médicale Cie IncDYB2019-09-23