FDA.reportPublic FDA data

NA

Primary DI
05415067042699
Brand
NA
Company
ST. JUDE MEDICAL, INC.
Model
405522
Catalog number
405522
Device description
Vessel Dilator
Published
2022-02-16
Public version status
New
Distribution status
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
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894330000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894330000DAIG VESSEL DILATORDaig Corp.1989-09-12DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067004802PreviousGS10
05415067042699PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067004802054150670048025415067004802
05415067042699054150670426995415067042699

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, single-useA sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French
Length19Centimeter

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734008242Fast-Cath™4061044061042015-03-20
05414734008266Fast-Cath™4061204061202015-03-20
05414734008280Fast-Cath™4061284061282015-03-20
05414734008303Fast-Cath™4061404061402015-03-12
05414734008327Fast-Cath™4061624061622015-02-28
05414734008341Maximum™4062504062502015-04-11
05414734008365Maximum™4062514062512015-04-11
05414734008389Maximum™4062524062522015-04-11
05414734008402Maximum™4062534062532015-04-11
05414734008426Maximum™4062554062552015-04-10
05414734008488Maximum™4062594062592015-04-11
05414734008501Maximum™4063474063472015-04-11
05414734008525Maximum™4063594063592015-04-11
05414734008549Maximum™4063694063692015-04-10
05414734008563Fast-Cath™4065404065402015-02-28
05414734008587Fast-Cath™4065424065422015-02-28
05414734008600Fast-Cath™4065444065442015-02-28
05414734008648Maximum™4066534066532015-04-10
05414734008662Maximum™4066634066632015-04-10
05414734008808ULTIMUM™4078314078312015-09-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00884450840597Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-27
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00884450732311Abiomed®Merit Medical Systems, Inc.DRE2023-06-30
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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