FDA.reportPublic FDA data

Vasoview EVH Accsessory Pack

Primary DI
00607567700376
Brand
Vasoview EVH Accsessory Pack
Company
MAQUET CARDIOVASCULAR LLC
Model
VH-2004
Catalog number
VH-2004
Device description
Vasoview EVH Accsessory Pack
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
GCJLaparoscope, General & Plastic Surgery
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041981000
K130121000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041981000GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004Guidant Corporation2004-08-20GEI
K130121000SHORT PORT BLUNT TIP TROCARBoston Scientific Corporation2013-04-11GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20607567700370PackageGS15In Commercial Distribution
00607567700376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2060756770037020607567700370
00607567700376006075677003766075677003760607567700376

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic scissors, reusableA hand-held flexible device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of mechanical (i.e., not electrosurgical) cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working channel of the endoscope. This is a reusable device.

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
00607567700772Active Return Cord non-sterileC-1838C-18382016-09-24
00607567700789BiPolar CableC-2838C-28382016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436827MillenniumAvalign Technologies, Inc.GCJ2026-10-22
00190776436858MillenniumAvalign Technologies, Inc.GEI2026-10-22
B382SD77105560Surgical DirectSurgical Direct, Inc.GEI2026-10-22
B382SD772553050Surgical DirectSurgical Direct, Inc.GCJ2026-10-22
00190776435677MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435684MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435752MillenniumAvalign Technologies, Inc.GEI2026-10-21
00190776435769MillenniumAvalign Technologies, Inc.GEI2026-10-21
00841019124192KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-21
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19