FDA.reportPublic FDA data

Visions PV .014P RX Digital IVUS Catheter

Primary DI
00845225002428
Brand
Visions PV .014P RX Digital IVUS Catheter
Company
Philips Image Guided Therapy Corporation
Model
85910P
Catalog number
85910P
Published
2016-08-23
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
ITXTransducer, Ultrasonic, Diagnostic
OBJCatheter, Ultrasound, Intravascular
OBLCement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
OBJCatheter, Ultrasound, IntravascularCardiovascular2
OBLCement, Bone, Pre-Formed, Modular, Polymeric, VertebroplastyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152829000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152829000Visions PV.014P RX Digital IVUS CatheterVolcano Corporation2015-11-19OBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845225002428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225002428008452250024288452250024280845225002428

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular ultrasound imaging catheter, single-useA flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes either a single or an array of transducer element(s) (piezoelectric, active, or crystal); it cannot be manoeuvred via controls (i.e., non-steerable). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
(800) 228-4728IGTD.CustomerInquiry@philips.com

Regulatory Flags#

DUNS number
018860556
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845225013011ICE PIMVSICEPIMVSICEPIM2026-07-30
00845225012939IntraSight Plus7974177974172026-05-26
00845225012946IntraSight Plus7974237974232026-05-26
00813132028824StellarexAB35SX040040080AB35SX0400400802022-01-05
00813132028763StellarexAB35SX060100135AB35SX0601001352022-01-13
00813132028770StellarexAB35SX040100135AB35SX0401001352022-01-13
00813132028787StellarexAB35SX040100080AB35SX0401000802022-01-13
00813132028794StellarexAB35SX050100080AB35SX0501000802022-01-13
00813132028800StellarexAB35SX060100080AB35SX0601000802022-01-13
00813132028817StellarexAB35SX050100135AB35SX0501001352022-01-13
00813132028831StellarexAB35SX040080080AB35SX0400800802022-01-13
00813132028848StellarexAB35SX040120080AB35SX0401200802022-01-13
00813132028855StellarexAB35SX050040080AB35SX0500400802022-01-13
00813132028862StellarexAB35SX050080080AB35SX0500800802022-01-13
00813132028879StellarexAB35SX050120080AB35SX0501200802022-01-13
00813132028886StellarexAB35SX060040080AB35SX0600400802022-01-13
00813132028893StellarexAB35SX060080080AB35SX0600800802022-01-13
00813132028909StellarexAB35SX060120080AB35SX0601200802022-01-13
00813132028916StellarexAB35SX040040135AB35SX0400401352022-01-13
00813132028923StellarexAB35SX040080135AB35SX0400801352022-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845225013011ICE PIMPhilips Image Guided Therapy CorporationOBJ2026-07-30
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10801902194654ARROWTELEFLEX INCORPORATEDOBJ2026-07-29
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