FDA.reportPublic FDA data

Venos Occlusion Balloon Catheter

Primary DI
00836559007074
Brand
Venos Occlusion Balloon Catheter
Company
Oscor Inc.
Model
V058015
Catalog number
V058015
Device description
Occlusion Balloon Catheter, 5F
Published
2017-11-30
Public version status
Update
Distribution status
Not 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
DYGCATHETER, FLOW DIRECTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYGCatheter, Flow DirectedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081052000OCCLUSION BALLOON CATHETER, MODEL VENOSOscor, Inc.2008-06-18DYG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00836559007074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00836559007074008365590070748365590070740836559007074

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac sizing catheterA sterile flexible tube with an inflatable balloon at the distal end designed for use in a patient with a cardiovascular defect wherein accurate measurement of the defect is important to select the appropriately sized occlusion device. It is typically designed to pass over a guidewire and it will have radiopaque marker bands along it distal end to assist in placement using fluoroscopy. It is made of plastic materials and metal [e, g, platinum (Pt) for the bands] and is available in a variety of designs and sizes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length80Centimeter
Outer Diameter1.7Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(727)937-2511sales@oscor.com

Regulatory Flags#

DUNS number
101835833
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00813502010664Introducer Kit for Impella®0052-30250052-30252017-11-30
00813502011517Introducer Kit for Impella®0052-30010052-30012017-11-30
00813502011562Introducer Kit for Impella®0052-30000052-30002017-11-30
00813502011609Introducer Kit for Impella®0052-30060052-30062017-11-19
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00885672012922Volante™VLT-6.5-55-9-SVLT-6.5-55-9-S2026-05-08
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00885672012946Volante™VLT-6.5-55-17-SVLT-6.5-55-17-S2026-05-08
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103000382SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
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