FDA.reportPublic FDA data

iCast covered stent system, 5mm x 32mm x 80cm

Primary DI
00650862485325
Brand
iCast covered stent system, 5mm x 32mm x 80cm
Company
Atrium Medical Corporation
Model
48532
Device description
iCast covered stent system, 5mm x 32mm x 80cm
Published
2026-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PRLIliac Covered Stent, Arterial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRLIliac Covered Stent, ArterialUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P120003009

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120003009iCast Covered Stent SystemAtrium Medical Corp.2023-03-22PRL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00650862485325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650862485325006508624853256508624853250650862485325

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral artery endovascular stent-graft, non-medicatedA non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to maintain patency and improve luminal diameter, typically in patients with symptomatic peripheral vascular disease or following the recanalization of a total occlusion. It may be intended for implantation in an artery adjacent to the aorta (e.g., iliac, renal), however it is not a dedicated component of an aortoiliac stent-graft assembly; it may additionally be intended for venous implantation. It is a metallic mesh-like structure with a synthetic polymer tube (endovascular graft); it does not include pharmaceuticals.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length80Centimeter
Stent Diameter5Millimeter
Stent Length32Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-943-8872customercare-US@getinge.com

Regulatory Flags#

DUNS number
051798999
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00650862122916iCast covered stent system, 12mm x 29mm x 80cmGBX12291A2026-02-18
00650862122923iCast covered stent system, 12mm x 29mm x 120cmGBX12292A2026-02-18
00650862124118iCast covered stent system, 12mm x 41mm x 80cmGBX12411A2026-02-18
00650862124125iCast covered stent system, 12mm x 41mm x 120cmGBX12412A2026-02-18
00650862126112iCast covered stent system, 12mm x 61mm x 80cmGBX12611A2026-02-18
00650862126129iCast covered stent system, 12mm x 61mm x 120cmGBX12612A2026-02-18
00650862425321iCast covered stent system, 5mm x 32mm x 120cm425322026-02-18
00650862426328iCast covered stent system, 6mm x 32mm x 120cm 426322026-02-18
00650862427325iCast covered stent system, 7mm x 32mm x 120cm427322026-02-18
00650862428322iCast covered stent system, 8mm x 32mm x 120cm428322026-02-18
00650862429329iCast covered stent system, 9mm x 32mm x 120cm429322026-02-18
00650862480597iCast covered stent system, 10mm x 59mm x 80cm480592026-02-18
00650862486322iCast covered stent system, 6mm x 32mm x 80cm 486322026-02-18
00650862487329iCast covered stent system, 7mm x 32mm x 80cm 487322026-02-18
00650862488326iCast covered stent system, 8mm x 32mm x 80cm 488322026-02-18
00650862489323iCast covered stent system, 9mm x 32mm x 80cm489322026-02-18
00650862720594iCast covered stent system, 10mm x 59mm x 120cm720592026-02-18
00650862420388iCast Covered Stent System, 10mmX38mmX120cm42038420382023-06-09
00650862425161iCast Covered Stent System, 5mmX16mmX120cm42516425162023-06-09
00650862425222iCast Covered Stent System, 5mmX22mmX120cm42522425222023-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650862122916iCast covered stent system, 12mm x 29mm x 80cmAtrium Medical CorporationPRL2026-02-18
00650862122923iCast covered stent system, 12mm x 29mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862124118iCast covered stent system, 12mm x 41mm x 80cmAtrium Medical CorporationPRL2026-02-18
00650862124125iCast covered stent system, 12mm x 41mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862126112iCast covered stent system, 12mm x 61mm x 80cmAtrium Medical CorporationPRL2026-02-18
00650862126129iCast covered stent system, 12mm x 61mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862425321iCast covered stent system, 5mm x 32mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862426328iCast covered stent system, 6mm x 32mm x 120cm Atrium Medical CorporationPRL2026-02-18
00650862427325iCast covered stent system, 7mm x 32mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862428322iCast covered stent system, 8mm x 32mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862429329iCast covered stent system, 9mm x 32mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862480597iCast covered stent system, 10mm x 59mm x 80cmAtrium Medical CorporationPRL2026-02-18
00650862486322iCast covered stent system, 6mm x 32mm x 80cm Atrium Medical CorporationPRL2026-02-18
00650862487329iCast covered stent system, 7mm x 32mm x 80cm Atrium Medical CorporationPRL2026-02-18
00650862488326iCast covered stent system, 8mm x 32mm x 80cm Atrium Medical CorporationPRL2026-02-18
00650862489323iCast covered stent system, 9mm x 32mm x 80cmAtrium Medical CorporationPRL2026-02-18
00650862720594iCast covered stent system, 10mm x 59mm x 120cmAtrium Medical CorporationPRL2026-02-18
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