FDA.reportPublic FDA data

Ultra IABP Catheter Kit

Primary DI
00837654076439
Brand
Ultra IABP Catheter Kit
Company
INSIGHTRA MEDICAL, INC.
Model
IMU7F-30
Device description
The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic balloon pumping circuit for the emergency treatment of patients in cardiogenic shock. This condition occurs in patients post acute myocardial infarction, or with reduced cardiac output post open-heart surgery.
Published
2015-03-17
Public version status
Update
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
DSPSystem, Balloon, Intra-Aortic And Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSPSystem, Balloon, Intra-Aortic And ControlCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082746000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082746000ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20Insightra Medical, Inc.2009-01-12DSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00837654076439PackageGS15In Commercial Distribution
00850012832492PackageGS15In Commercial Distribution
00850012832485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00837654076439008376540764398376540764390837654076439
00850012832492008500128324928500128324920850012832492
00850012832485008500128324858500128324850850012832485

GMDN Terms#

Term, Definition table
TermDefinition
Intra-aortic balloon catheterA flexible, balloon-tipped, tube that is placed in the aorta distal to the aortic valve to augment the heart's pumping capability. It is typically introduced percutaneously via one of the femoral arteries and advanced to the descending thoracic aorta using fluoroscopic imaging guidance. Once positioned, an external pump alternately inflates and deflates the balloon in a cycle counter to the cardiac cycle (counter pulsation), facilitating ejection during systole and limits regurgitation during diastole. It is used to treat several cardiovascular conditions, e.g., after open-heart surgery, cardiogenic shock, intractable angina, or to reduce myocardial conditions. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge7French
Total Volume30Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-215-1835raqa@insightra.com
931-919-2955raqa@insightra.com

Regulatory Flags#

DUNS number
097664937
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00013964672237Modulare Stabilization DeviceM-CVC/PICCSP2015-03-16
00013964672077Modulare Stabilization DeviceM-CVC/PICC2015-03-16
00850012832010Freedom - ProFlor Inguinal Hernia ImplantFIHR 25mmFIHR 25mm2015-07-22
00850012832072Freedom - ProFlor Inguinal Hernia ImplantFIHR 40mmFIHR 40mm2015-07-22
00850012832102Freedom - ProFlor Inguinal Hernia ImplantFIHR 40mmEFIHR 40mmE2015-07-22
00850012832218Freedom - Ventral Hernia Repair SystemFVHR12X15FVHR12X152015-07-22
00850012832287Freedom - Ventral Hernia Repair SystemFVHR20X30FVHR20X302015-07-22
00850012832317Freedom - Ventral Hernia Repair SystemFVHR28X35FVHR28X352015-07-22
00850012832041Freedom - ProFlor Inguinal Hernia ImplantFIHR 25mmEFIHR 25mmE2015-07-22
00850012832256Freedom - Ventral Hernia Repair SystemFVHR15X25FVHR15X252015-07-22
00850012832348Freedom - Ventral Hernia Repair SystemFVHR35X45FVHR35X452015-07-22
00013964672152Freedom - ProFlor Inguinal Hernia KitFIHR 40mmEKFIHR 40mmEK2015-07-22
00013964672367Freedom - ProFlor Inguinal Hernia KitFIHR 25mmEKFIHR 25mmEK2015-07-22
00837654352878Freedom - ProFlor Inguinal Hernia KitFIHR 25mmKFIHR 25mmK2015-07-22
00837654352885Freedom - ProFlor Inguinal Hernia KitFIHR 40mmKFIHR 40mmK2015-07-22
17350021986129PowerPumpTM dp System Day Cassette9410122016-09-24
17350021986136PowerPumpTM dp System Patient cassette9410132016-09-24
17350021986143PowerPumpTM dp System Patient tubing9410142016-09-24
07350021981004Double Pump Day cassette/ Double Pump RF Day cassette10020532016-09-24
07350021981509Double Pump Single/ Double Pump RF Single10020522016-09-24

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