FDA.reportPublic FDA data

AngioDynamics

Primary DI
25051684023013
Brand
AngioDynamics
Company
Angiodynamics, Inc.
Model
45758
Device description
Mini Stick MAX Coaxial Microintroducer Kit
Published
2024-10-18
Public version status
New
Distribution status
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
25051684023013PackageGS110In Commercial Distribution
H965457580PreviousHIBCC0
15051684023016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2505168402301325051684023013
1505168402301615051684023016

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 typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French
Length10Centimeter
Lumen/Inner Diameter0.5Millimeter
Outer Diameter1.42Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079252781
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
H787065068010Micro Access065068012016-09-20
H787065068020Micro Access065068022016-09-20
H787065068030Micro Access065068032016-09-20
H787065068040Micro Access065068042016-09-20
H787065068050Micro Access065068052016-09-20
H787065072010Micro Access065072012016-09-20
H787065072020Micro Access065072022016-09-20
H787065072030Micro Access065072032016-09-20
H787065072040Micro Access065072042016-09-20
H787065072100Morpheus065072102016-09-20
H787065072110Morpheus065072112016-09-20
H787065072120Morpheus065072122016-09-20
H787065072130Morpheus065072132016-09-20
H787065076010Embosafe065076012016-09-20
H787065076020Embosafe065076022016-09-20
H787065076030Embosafe065076032016-09-20
H787065084020Morpheus065084022016-09-20
H787065084030Morpheus065084032016-09-20
H787065084040Morpheus065084042016-09-20
H787065086010Micro Access065086012016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450840610Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-20
00884450838105Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-03
00884450839119Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-03
00884450838143Prelude Roadster™Merit Medical Systems, Inc.DRE2026-09-03
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
00884450838365Abiomed®Merit Medical Systems, Inc.DRE2025-07-01
00884450770764Prelude Roadster™Merit Medical Systems, Inc.DRE2023-12-13
00884450770771Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-28
00884450770788Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-11
00884450770757Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-05
00884450732311Abiomed®Merit Medical Systems, Inc.DRE2023-06-30
00884450532577Prelude Roadster™Merit Medical Systems, Inc.DRE2022-12-28
00884450532522Prelude Roadster™Merit Medical Systems, Inc.DRE2022-12-15
00884450531952Prelude Roadster™Merit Medical Systems, Inc.DRE2022-11-12
00884450532348Prelude Roadster™Merit Medical Systems, Inc.DRE2022-11-01
00884450532171Prelude Roadster™Merit Medical Systems, Inc.DRE2022-10-28
00884450531914Prelude Roadster™Merit Medical Systems, Inc.DRE2022-10-19
00884450532607Prelude Roadster™Merit Medical Systems, Inc.DRE2022-10-01
00884450532515Prelude Roadster™Merit Medical Systems, Inc.DRE2022-09-14
00884450531921Prelude Roadster™Merit Medical Systems, Inc.DRE2022-09-13
00884450532065Prelude Roadster™Merit Medical Systems, Inc.DRE2022-08-30
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