FDA.reportPublic FDA data

TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator

Primary DI
20705032009451
Brand
TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator
Company
CORDIS CORPORATION
Model
466P306AU
Catalog number
466P306AU
Published
2015-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020316000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020316000CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BUCordis Corp.2002-03-20DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032009451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503200945120705032009451

GMDN Terms#

Term, Definition table
TermDefinition
Vena cava filter, permanentA permanently implanted vascular device intended to be percutaneously placed in the inferior vena cava (IVC) to prevent pulmonary embolism (PE). The device achieves its unconstrained diameter upon deployment in the IVC and imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. It is designed for blood clot capture while maintaining caval patency. It is made of metal alloys [e.g., stainless steel, titanium (Ti), nickel-titanium alloy (Nitinol)] and is available in various self-expanding, wire designs (e.g., conical, basket).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806136177
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032019057VISTA BRITE TIP598941P598941P2024-02-23
10705032019170VISTA BRITE TIP598949P598949P2024-02-23
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10705032043069VISTA BRITE TIPSM7540SM75402024-02-23
10705032043144VISTA BRITE TIPSM7548SM75482024-02-23
10705032043151VISTA BRITE TIPSM7549SM75492024-02-23
10705032043434VISTA BRITE TIPSM7596SM75962024-02-23
10705032043779VISTA BRITE TIPSM7652SM76522024-02-23
10705032047050VISTA BRITE TIPSRA0002IGSRA0002IG2024-02-23
10705032047135VISTA BRITE TIPSRA0016IGSRA0016IG2024-02-23
10705032056625ATW Marker Wire Steerable Guidewires595MEJ014595MEJ0142021-01-26
20705032064863VISTA BRITE TIPSM7732SM77322024-02-23
20705032064870VISTA BRITE TIPSM7733SM77332024-02-23
20705032064887VISTA BRITE TIPSM7731SM77312024-02-23
20705032065143VISTA BRITE TIPSM7737SM77372024-02-23
10705032017169VISTA BRITE TIP588823E588823E2016-08-01
10705032017268VISTA BRITE TIP588830E588830E2016-08-01
10705032017299VISTA BRITE TIP588831E588831E2016-08-01
10705032017343VISTA BRITE TIP588834E588834E2016-08-01

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