FDA.reportPublic FDA data

Terumo Aortic Balloon

Primary DI
00853892004447
Brand
Terumo Aortic Balloon
Company
QXMEDICAL
Model
120cm
Catalog number
28-W1-50-08-120G
Device description
Aortic Balloon Catheter, 120cm
Published
2021-09-03
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
MJNCatheter, Intravascular Occluding, Temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
MJNCatheter, Intravascular Occluding, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120381000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120381000Q50 PLUS STENT GRAFT BALLOON CATHETERQxmedical, LLC2012-02-24DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853892004447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853892004447008538920044478538920044470853892004447

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length120Centimeter
Introducer Sheath Compatibilit10French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-842-2050admin@qxmedical.com

Regulatory Flags#

DUNS number
022672652
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853892004140Camaro Support CatheterCAM-035-180CAM-035-1802020-07-14
00853892004157Camaro Support CatheterCAM-035-150CAM-035-1502020-07-14
00853892004164Camaro Support CatheterCAM-035-135CAM-035-1352020-07-14
00853892004171Camaro Support CatheterCAM-035-090CAM-035-0902020-07-14
00853892004188Camaro Support CatheterCAM-035-065CAM-035-0652020-07-14
00853892004195Camaro Support CatheterCAM-018-180CAM-018-1802020-07-14
00853892004201Camaro Support CatheterCAM-018-150CAM-018-1502020-07-14
00853892004218Camaro Support CatheterCAM-018-135CAM-018-1352020-07-14
00853892004225Camaro Support CatheterCAM-018-090CAM-018-0902020-07-14
00853892004232Camaro Support CatheterCAM-018-065CAM-018-0652020-07-14
00853892004249Camaro Support CatheterCAM-014-180CAM-014-1802020-07-14
00853892004256Camaro Support CatheterCAM-014-150CAM-014-1502020-07-14
00853892004263Camaro Support CatheterCAM-014-135CAM-014-1352020-07-14
00853892004270Camaro Support CatheterCAM-014-090CAM-014-0902020-07-14
00853892004287Camaro Support CatheterCAM-014-065CAM-014-0652020-07-14
00853892004027Boosting CatheterBC57-150BC57-1502016-11-23
00853892004034Boosting CatheterBC63-150BC63-1502017-01-06
00853892004041Boosting CatheterBC72-150BC72-1502018-07-11
00853892004058Boosting CatheterBC52-150BC52-1502018-07-11
00853892004119VitaleVITB08VITB082019-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
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00199150070138NAMEDTRONIC, INC.DQY2026-04-13
00199150070145NAMEDTRONIC, INC.DQY2026-04-13
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
00191506019563Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
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00191506019785Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019808Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019822Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019846Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019860Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019884Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00389701012896R2P NAVICROSSTERUMO MEDICAL CORPORATIONDQY2024-01-11
00389701012902R2P NAVICROSSTERUMO MEDICAL CORPORATIONDQY2024-01-11
10801902215502ARROWTELEFLEX INCORPORATEDDQY2023-07-10
10801902215267ARROWTELEFLEX INCORPORATEDDQY2023-07-07