FDA.reportPublic FDA data

Tensure

Primary DI
M95580020
Brand
Tensure
Company
SENTREHEART, INC
Model
7 lb
Catalog number
8002
Device description
A sterile, manual, hand-held surgical device intended for controlled tightening of a ligature loop in situ (e.g., during vascular surgery). The ligature is intended to be loaded into the device, which typically includes a sliding mechanism, allowing controlled manual tightening; the device may also include tightening markers. This is a single-use device
Published
2018-09-17
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
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M95580020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ligature loop tightenerA hand-held manual surgical instrument intended for controlled tightening of a ligature/suture loop in situ during open and/or minimally-invasive surgery (e.g., during vascular surgery). The suture is intended to be loaded into the device, which typically includes a sliding mechanism or a rigid tube with an internal wire loop, allowing controlled manual tightening; the device may also include tightening markers. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650-354-1200info@sentreheart.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M95520060EndoCATH200620062016-09-23
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
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00198506092428ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00840456202104JMUJMU DENTAL, INCMDM2026-07-27
00840456215760JMUJMU DENTAL, INCMDM2026-07-27