FDA.reportPublic FDA data

AngioDynamics

Primary DI
H965457570
Brand
AngioDynamics
Company
NAVILYST MEDICAL, INC.
Model
45757
Device description
Mini Stick MAX Coaxial Microintroducer Kit
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132713000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132713000NMI COAXIAL MICROINTRODUCER SETNavilyst Medical, Inc.2013-09-27DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H965457571PackageHIBCC10Not in Commercial Distribution
H965457570PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator and/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0
Length0
Lumen/Inner Diameter0
Outer Diameter0

Contacts#

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

Regulatory Flags#

DUNS number
809699023
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
H74904490200NAMIC04490202016-09-20
H965457480AngioDynamics457482016-09-20
H965457490AngioDynamics457492016-09-20
H965457500AngioDynamics457502016-09-20
H965457510AngioDynamics457512016-09-20
H965457520AngioDynamics457522016-09-20
H965457530AngioDynamics457532016-09-20
H965457540AngioDynamics457542016-09-20
H965457550AngioDynamics457552016-09-20
H965457560AngioDynamics457562016-09-20
H965457580AngioDynamics457582016-09-20
H965457590AngioDynamics457592016-09-20
H965457600AngioDynamics457602016-09-20
H965457610AngioDynamics457612016-09-20
H965457620AngioDynamics457622016-09-20
H965457630AngioDynamics457632016-09-20
H965457640AngioDynamics457642016-09-20
H965457650AngioDynamics457652016-09-20
H965457660AngioDynamics457662016-09-20
H965457670AngioDynamics457672016-09-20

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Primary DI, Brand, Company table
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00884450839126Prelude Roadster™Merit Medical Systems, Inc.DRE2026-09-03
00884450838204Prelude Roadster™Merit Medical Systems, Inc.DRE2026-09-02
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-27
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-18
00884450838136Prelude Roadster™Merit Medical Systems, Inc.DRE2026-07-31
00884450839133Prelude Roadster™Merit Medical Systems, Inc.DRE2026-06-19
00884450839140Prelude Roadster™Merit Medical Systems, Inc.DRE2026-05-09
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00884450770771Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-28
00884450770788Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-11
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00884450732311Abiomed®Merit Medical Systems, Inc.DRE2023-06-30
00884450532577Prelude Roadster™Merit Medical Systems, Inc.DRE2022-12-28
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00884450532591Prelude Roadster™Merit Medical Systems, Inc.DRE2022-08-30
00884450532553Prelude Roadster™Merit Medical Systems, Inc.DRE2022-08-23
00884450557501Prelude Roadster™Merit Medical Systems, Inc.DRE2022-08-23