FDA.reportPublic FDA data

Amplatzer™ TorqVue™ 45° x 45°

Primary DI
05415067025883
Brand
Amplatzer™ TorqVue™ 45° x 45°
Company
AGA MEDICAL CORPORATION
Model
Delivery Sheath
Catalog number
9-TV45X45-12F-080
Device description
Delivery Sheath
Published
2017-02-25
Public version status
Update
Distribution status
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
DQYCATHETER, PERCUTANEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163000000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163000000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO2016-12-23DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067025883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067025883054150670258835415067025883

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac occluder delivery kitA collection of sterile devices designed to implant a cardiac occluder for the non-surgical closure of cardiac defects. The collection may include a delivery catheter/sheath, dilator, loading device, delivery cable, and additional items for the intravascular delivery and deployment of a cardiac occlude; the cardiac occluder is not included. The devices are used in the treatment of cardiac disorders that may include (but not limited to) atrial septal defects (ASD), ventricular septal defects (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Length80Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
966215829
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811806014111AMPLATZER™9-TV45X45-14F-1009-TV45X45-14F-1002015-03-09
05415067019127Amplatzer™9-ASD-0049-ASD-0042015-01-27
05415067019134AMPLATZER™9-ASD-0059-ASD-0052015-01-27
05415067019141AMPLATZER™9-ASD-0069-ASD-0062015-01-27
05415067019158AMPLATZER™9-ASD-0079-ASD-0072015-01-27
05415067019165AMPLATZER™9-ASD-0089-ASD-0082015-01-27
05415067019172AMPLATZER™9-ASD-0099-ASD-0092015-01-27
05415067019189AMPLATZER™9-ASD-0109-ASD-0102015-01-27
05415067019196AMPLATZER™9-ASD-0119-ASD-0112015-01-27
05415067019202AMPLATZER™9-ASD-0129-ASD-0122015-01-27
05415067019219Amplatzer™9-ASD-0139-ASD-0132015-01-27
05415067019226Amplatzer™9-ASD-0149-ASD-0142015-01-27
05415067019233Amplatzer™9-ASD-0159-ASD-0152015-01-27
05415067019240Amplatzer™9-ASD-0169-ASD-0162015-01-27
05415067019257Amplatzer™9-ASD-0179-ASD-0172015-01-27
05415067019264Amplatzer™9-ASD-0189-ASD-0182015-01-27
05415067019271Amplatzer™9-ASD-0199-ASD-0192015-01-27
05415067019288Amplatzer™9-ASD-0209-ASD-0202015-01-27
05415067019295Amplatzer™9-ASD-0229-ASD-0222015-01-27
05415067019301Amplatzer™9-ASD-0249-ASD-0242015-01-27

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Primary DI, Brand, Company table
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