FDA.reportPublic FDA data

TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator

Primary DI
20705032009475
Brand
TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator
Company
Cordis US Corp.
Model
466P306BU
Catalog number
466P306BU
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
DREDilator, Vessel, For Percutaneous Catheterization
DTKFilter, Intravascular, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2
DTKFilter, Intravascular, CardiovascularCardiovascular2

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
20705032009475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503200947520705032009475

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
118274128
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
10705032100557VISTA BRITE TIP588-842PM588-842PM2024-09-09
10705032100571VISTA BRITE TIP670-052-00M670-052-00M2024-09-09
10705032100595VISTA BRITE TIP670-002-00M670-002-00M2024-09-09
10705032100618VISTA BRITE TIP778-054-00M778-054-00M2024-09-09
10705032100625VISTA BRITE TIP670-034-00M670-034-00M2024-09-09
10705032100649VISTA BRITE TIP670-083-00M670-083-00M2024-09-09
10705032100656VISTA BRITE TIP778-052-00M778-052-00M2024-09-09
10705032100663VISTA BRITE TIP778-082-00M778-082-00M2024-09-09
10705032100670VISTA BRITE TIP670-036-00M670-036-00M2024-09-09
10705032100694VISTA BRITE TIP556-082-0LM556-082-0LM2024-09-09
10705032100700VISTA BRITE TIP670-110-00M670-110-00M2024-09-09
10705032100731VISTA BRITE TIP670-112-00M670-112-00M2024-09-09
10705032100748VISTA BRITE TIP670-190-00M670-190-00M2024-09-09
10705032100755VISTA BRITE TIP778-055-00M778-055-00M2024-09-09
10705032100762VISTA BRITE TIP670-055-00M670-055-00M2024-09-09
10705032100779VISTA BRITE TIP556-002-0LM556-002-0LM2024-09-09
10705032100793VISTA BRITE TIP556-080-0LM556-080-0LM2024-09-09
10705032100809VISTA BRITE TIP670-005-00M670-005-00M2024-09-09
10705032100816VISTA BRITE TIP556-054-0LM556-054-0LM2024-09-09
10705032100823VISTA BRITE TIP778-037-00M778-037-00M2024-09-09

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