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
B382SD9176201020Surgical DirectSurgical Direct, Inc.MDM2026-07-13
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00810158210615PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00810158215917PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713015PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713039PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713046PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713053PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
03661219436522LANDANGERLANDANGERMDM2026-07-08
03661219436584LANDANGERLANDANGERMDM2026-07-08
03661219436706LANDANGERLANDANGERMDM2026-07-08
04054462915583evonosevonos GmbH & Co. KGMDM2026-06-25
00198506091612ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00198506091629ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
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00198506091353ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
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B356KE392100American MedicalsAmerican MedicalsMDM2026-05-29
B356KE396100American MedicalsAmerican MedicalsMDM2026-05-29
08800042700102Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29