FDA.reportPublic FDA data

Viance™

Primary DI
00821684073759
Brand
Viance™
Company
EV3, INC
Model
VNC-SD-150
Device description
CATH VNC-SD-150 CTO CROSSING V05
Published
2016-09-18
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
PDUCatheter for crossing total occlusions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDUCatheter For Crossing Total OcclusionsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113589000
K120533000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113589000BIGBOSS CATHETERBridgepoint Medical2012-01-04DQY
K120533000BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRESBridgepoint Medical2012-05-22PDU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821684073759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821684073759008216840737598216840737590821684073759

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge5French
Length150Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
117446916
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150028399Liberant™LMT-TRX2026-05-07
00821684071397Protégé™ GPS™SERB65-09-20-1202015-09-04
00821684071403Protégé™ GPS™SERB65-09-20-802015-09-04
00821684071410Protégé™ GPS™SERB65-09-30-1202015-09-04
00821684071427Protégé™ GPS™SERB65-09-30-802015-09-04
00821684071434Protégé™ GPS™SERB65-09-40-1202015-09-04
00821684071441Protégé™ GPS™SERB65-09-40-802015-09-04
00821684071458Protégé™ GPS™SERB65-09-60-1202015-09-04
00821684071465Protégé™ GPS™SERB65-09-60-802015-09-04
00821684071472Protégé™ GPS™SERB65-09-80-1202015-09-04
00821684071489Protégé™ GPS™SERB65-09-80-802015-09-04
00821684071496Protégé™ GPS™SERB65-10-20-1202015-09-01
00821684071502Protégé™ GPS™SERB65-10-20-802015-09-01
00821684071519Protégé™ GPS™SERB65-10-30-1202015-09-01
00821684071526Protégé™ GPS™SERB65-10-30-802015-09-01
00821684071533Protégé™ GPS™SERB65-10-40-1202015-09-01
00821684071540Protégé™ GPS™SERB65-10-40-802015-09-01
00821684071557Protégé™ GPS™SERB65-10-60-1202015-09-01
00821684071564Protégé™ GPS™SERB65-10-60-802015-09-01
00821684071571Protégé™ GPS™SERB65-10-80-1202015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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07540299000488PowerWire 14 Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2025-12-04
00860009199705Santreva-ATK Endovascular Revascularization CatheterAngiosafe, Inc.PDU2025-12-03
00845225003425Pioneer Plus CatheterPhilips Image Guided Therapy CorporationPDU2024-08-12
00850041730158LimFlow ARCInari Medical, Inc.PDU2024-04-19
07540299000372PowerWire Pro Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2024-03-18
07540299000389PowerWire Pro Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2024-03-18
07540299000396PowerWire Pro Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2024-03-18
07540299000402PowerWire Pro Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2024-03-18
07540299000419PowerWire Pro Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2024-03-18
00851354004554Tigereye STAVINGER, INC.PDU2023-07-24
00850041730011LimFlow ARCInari Medical, Inc.PDU2023-06-26
07540299000228PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000235PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000242PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000259PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000266PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000273PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
04260279096456BeBack Crossing CatheterBentley InnoMed GmbHPDU2023-04-24
04260279096463BeBack Crossing CatheterBentley InnoMed GmbHPDU2023-04-24
04260279096470BeBack Crossing CatheterBentley InnoMed GmbHPDU2023-04-24
04260279096487BeBack Crossing CatheterBentley InnoMed GmbHPDU2023-04-24
00851354004493TigereyeAVINGER, INC.PDU2023-03-14
07290017837109GoBack Crossing CatheterUPSTREAM PERIPHERAL TECHNOLOGIES LTDPDU2022-10-19
07290017837116GoBack Crossing CatheterUPSTREAM PERIPHERAL TECHNOLOGIES LTDPDU2022-10-19
07290017837222GoBack Crossing CatheterUPSTREAM PERIPHERAL TECHNOLOGIES LTDPDU2022-10-19
07290017837239GoBack Crossing CatheterUPSTREAM PERIPHERAL TECHNOLOGIES LTDPDU2022-10-19
00801741202438Recanalization SystemBard Peripheral Vascular, Inc.PDU2022-03-30