FDA.reportPublic FDA data

iCast Covered Stent System, 5mmX22mmX120cm

Primary DI
00650862425222
Brand
iCast Covered Stent System, 5mmX22mmX120cm
Company
Atrium Medical Corporation
Model
42522
Catalog number
42522
Device description
iCast Covered Stent System, 5mmX22mmX120cm
Published
2023-06-09
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
P120003000
P120003001
P120003002
P120003003
P120003004
P120003005
P120003006

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120003000iCast Covered Stent SystemAtrium Medical Corp.2023-03-22PRL
P120003001iCast Covered Stent SystemAtrium Medical Corp.2023-03-22PRL
P120003002iCast Covered Stent SystemAtrium Medical Corp.2023-03-22PRL
P120003003iCast Covered Stent SystemAtrium Medical Corp.2023-03-22PRL
P120003004iCast Covered Stent SystemAtrium Medical Corp.2023-03-22PRL
P120003005iCast Covered Stent SystemAtrium Medical Corp.2023-03-22PRL
P120003006iCast Covered Stent SystemAtrium Medical Corp.2023-03-22PRL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00650862425222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650862425222006508624252226508624252220650862425222

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 coronary 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 in addition be intended for optional venous implantation. It does not include anticoagulant or antiproliferative pharmaceuticals. It is a metallic outer mesh-like structure with an inner synthetic polymer tube (endovascular graft) available in various sizes. It is percutaneously inserted with a disposable delivery device which may be included with the stent-graft.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length120Centimeter
Stent Diameter5Millimeter
Stent Length22Millimeter

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
00650862485325iCast covered stent system, 5mm x 32mm x 80cm485322026-02-18
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

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
00650862485325iCast covered stent system, 5mm x 32mm 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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00733132658312GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
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