FDA.reportPublic FDA data

EndoCATH

Primary DI
M95520060
Brand
EndoCATH
Company
SENTREHEART, INC
Model
2006
Catalog number
2006
Device description
Large Occlusion Balloon Catheter
Published
2016-09-23
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
K070126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070126000OCCLUSION BALLOON CATHETERSentreheart, Inc.2008-02-08DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M95520060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA non-powered 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 aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-256-7330info@sentreheart.com

Regulatory Flags#

DUNS number
068810802
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M95580020Tensure7 lb80022018-09-17
M95550010SureCUT500150012018-09-17
M95560020SofTIPLong60022018-09-17
M95530050LariatIII30052016-09-23
M95530060LariatRS2016-10-14
M95540050FindrWIRZ400540052016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810024671953SSPC NXT Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-06-01
08718481740330Guidion ShortIMDS Operations B.V.DQY2026-06-01
08718481740347FlowGuideIMDS Operations B.V.DQY2026-06-01
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
00763000270353Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270377Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270537Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270551Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270216Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270230Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270254Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270292Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270315Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270339Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270391Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270414Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270438Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270476Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270490Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270513Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270582Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270605Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270667Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
07613327417203AXS Catalyst 7Stryker CorporationDQY2019-05-13
07613327417227AXS Catalyst 7Stryker CorporationDQY2019-05-13
00847536041707PhenomTM 17 CatheterMicro Therapeutics, Inc.DQY2019-04-22
00847536041752PhenomTM 17 CatheterMicro Therapeutics, Inc.DQY2019-04-22
00847536041769PhenomTM 17 CatheterMicro Therapeutics, Inc.DQY2019-04-22
00847536041776PhenomTM 17 CatheterMicro Therapeutics, Inc.DQY2019-04-22