FDA.reportPublic FDA data

Heartstring III System 4.3MM

Primary DI
00607567700321
Brand
Heartstring III System 4.3MM
Company
MAQUET CARDIOVASCULAR LLC
Model
HSK-3043
Catalog number
HSK-3043
Device description
Heartstring III System 4.3MM
Published
2016-09-24
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
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130382000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130382000HEARTSTRING III PROXIMAL SEAL SYSTEMBoston Scientific Corporation2013-06-05DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00607567700321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00607567700321006075677003216075677003210607567700321

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular anastomosis occluderA sterile device designed to temporarily occlude the flow of blood in the lumen of a blood vessel at a vascular anastomosis, primarily to control bleeding and enable operative field visualization during coronary or peripheral vascular bypass grafting and vessel repair surgery. It is typically designed as a flexible shaft with dilated/bulbous ends that is entirely inserted into the vessel lumen via a small incision at the surgical site to arrest blood flow at the anastomosis; it will typically have an external tab or tether used for its removal. It is typically made of silicone elastomer and polyester radiopaque materials and is available in a range of diameters. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4.3Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-880-2874cssurgery@maquet.com

Regulatory Flags#

DUNS number
022348156
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00384409005546Fusion Vascular GraftsM002015010260M0020150102602015-10-24
00384409005553Fusion Vascular GraftsM002015010410M0020150104102015-10-24
00384409005560Fusion Vascular GraftsM002015010450M0020150104502015-10-24
00384409005577Fusion Vascular GraftsM002015010460M0020150104602015-10-24
00384409005584Fusion Vascular GraftsM002015010470M0020150104702015-10-24
00384409005591Fusion Vascular GraftsM002015010480M0020150104802015-10-24
00384409005607Fusion Vascular GraftsM002015010660M0020150106602015-10-24
00384409005614Fusion Vascular GraftsM002015010680M0020150106802015-10-24
00384409005621Fusion Vascular GraftsM002015010810M0020150108102015-10-24
00384409005638Fusion Vascular GraftsM002015010850M0020150108502015-10-24
00384409005645Fusion Vascular GraftsM002015010860M0020150108602015-10-24
00384409005652Fusion Vascular GraftsM002015010870M0020150108702015-10-24
00384409005669Fusion Vascular GraftsM002015010880M0020150108802015-10-24
00384409005676Fusion Supported Vascular GraftsM002015030410M0020150304102015-10-24
00384409005683Fusion Supported Vascular GraftsM002015030450M0020150304502015-10-24
00384409005690Fusion Supported Vascular GraftsM002015030460M0020150304602015-10-24
00384409005706Fusion Supported Vascular GraftsM002015030470M0020150304702015-10-24
00384409005713Fusion Supported Vascular GraftsM002015030480M0020150304802015-10-24
00607567700376Vasoview EVH Accsessory PackVH-2004VH-20042016-09-24
00607567700772Active Return Cord non-sterileC-1838C-18382016-09-24

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Primary DI, Brand, Company table
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00190776395711MillenniumAvalign Technologies, Inc.DXC2026-07-14
00192896123557Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2026-07-10
00846159036152SCANLAN® Bulldog ClampSCANLAN INTERNATIONAL INCDXC2026-06-23
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