FDA.reportPublic FDA data

Amplatzer™

Primary DI
05415067036025
Brand
Amplatzer™
Company
ST. JUDE MEDICAL, INC.
Model
ASDS-14F-075
Catalog number
ASDS-14F-075
Device description
Steerable Delivery Sheath
Published
2021-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067036025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067036025054150670360255415067036025

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac occluder delivery kitA collection of devices designed to implant a cardiac occluder (not included) 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 occluder. The devices are used in the treatment of cardiac disorders that may include 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
Length75Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
149818952
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734509138NA3630W3630W2026-03-04
05415067056009Volt™K-VOLT-HDI-MK-VOLT-HDI-M2026-02-25
05415067056016Volt™K-VOLT-HDI-SK-VOLT-HDI-S2026-02-25
05415067056023Volt™K-VOLT-I-MK-VOLT-I-M2026-02-25
05415067056030Volt™K-VOLT-I-SK-VOLT-I-S2026-02-25
05415067055507Zenex MRI™PM1283PM12832026-01-22
05415067055514Zenex MRI™PM2283PM22832026-01-22
05415067036650Navitor™NVTR-LS-LGNVTR-LS-LG2023-01-16
05415067036667Navitor™NVTR-LS-SMNVTR-LS-SM2023-01-16
05415067055613EnSite™ENSITE-SW-06ENSITE-SW-062026-01-08
05415067051417Current™PFA-ECG-LNAMPFA-ECG-LNAM2026-01-06
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051554Current™PFA-ECG-CBLPFA-ECG-CBL2026-01-06
05415067051615Current™PFA-ECG-RNAMPFA-ECG-RNAM2026-01-06
05415067051721Current™PFA-GEN-CARTPFA-GEN-CART2026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067051813Current™GEN-3RD-RECGEN-3RD-REC2026-01-06
05415067052919Current™PFA-CIM-CBLPFA-CIM-CBL2026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05415067053886Current™PFA-GEN-V101PFA-GEN-V1012026-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04544050121057CELLO II Balloon Guide Catheter, 8F 90cmFUJI SYSTEMS CORPORATIONDQY2026-05-25
00763000821296Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821302Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821319Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821326Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821333Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821340Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821357Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821364Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821371Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821388Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821395Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821425Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821432Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821449Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821456Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821463Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821470Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821487Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821500Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
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20801902195429ARROWTELEFLEX INCORPORATEDDQY2026-03-17
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05