FDA.reportPublic FDA data

Micro-Access Introducer

Primary DI
00886333226931
Brand
Micro-Access Introducer
Company
ARGON MEDICAL DEVICES, INC.
Model
497837
Catalog number
497837
Device description
1S OneStic Micro-Access Introducer 6F x 7cm
Published
2026-10-07
Public version status
Update
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
K780126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K780126000DILATOR, VESSEL & INTRODUCER, SHEATHArgon Medical Corp.1978-03-02DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886333226938PackageGS110In Commercial Distribution
20886333226935PackageGS150In Commercial Distribution
00886333226931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088633322693810886333226938
2088633322693520886333226935
00886333226931008863332269318863332269310886333226931

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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and away from sunlight

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
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
true
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
00886333226948Micro-Access Introducer4978394978392026-10-07
00886333004171V•Stick™ Vascular Access Set390204400E390204400E2016-09-16
00886333004188V•Stick™ Vascular Access Set391504000E391504000E2016-09-16
00886333004195V•Stick™ Vascular Access Set391504300E391504300E2016-09-16
00886333004201V•Stick™ Vascular Access Set391504400E391504400E2016-09-16
00886333004218V•Stick™ Vascular Access Set391504500E391504500E2016-09-16
00886333004225V•Stick™ Vascular Access Set391505000E391505000E2016-09-16
00886333004232V•Stick™ Vascular Access Set391505300E391505300E2016-09-16
00886333004249V•Stick™ Vascular Access Set391505400E391505400E2016-09-16
00886333004256V•Stick™ Vascular Access Set391505500E391505500E2016-09-16
00886333004263V•Stick™ Vascular Access Set391605300E391605300E2016-09-16
00886333004270V•Stick™ Vascular Access Set391604000E391604000E2016-09-16
00886333004287V•Stick™ Vascular Access Set391604300E391604300E2016-09-16
00886333004294V•Stick™ Vascular Access Set391604400E391604400E2016-09-16
00886333004300V•Stick™ Vascular Access Set391604500E391604500E2016-09-16
00886333004317V•Stick™ Vascular Access Set391605000E391605000E2016-09-16
00886333004324V•Stick™ Vascular Access Set391605400E391605400E2016-09-16
00886333004331V•Stick™ Vascular Access Set391605500E391605500E2016-09-16
00886333007042V•Stick™ Vascular Access Set391705400E391705400E2016-09-16
00886333007059V•Stick™ Vascular Access Set391704400E391704400E2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450838129Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-29
10884450708443Prelude®Merit Medical Systems, Inc.DRE2026-10-29
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