FDA.reportPublic FDA data

Visions PV .014P RX Digital IVUS Catheter

Primary DI
00845225003319
Brand
Visions PV .014P RX Digital IVUS Catheter
Company
Philips Image Guided Therapy Corporation
Model
014R
Catalog number
014R
Device description
Visions PV .014P rapid exchange digital intravascular ultrasound catheter
Published
2025-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
OBJCatheter, Ultrasound, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
OBJCatheter, Ultrasound, IntravascularCardiovascular2

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
00845225003319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225003319008452250033198452250033190845225003319

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
Device Size Text, specify0
Length150Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature-29 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-20.2 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 228-4728IGTD.CustomerInquiry@philips.com

Regulatory Flags#

DUNS number
118354223
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
00813132029326Quick-Cross Support Catheter518-032518-0322022-02-22
00813132029333Quick-Cross Support Catheter518-033518-0332022-02-22
00813132029340Quick-Cross Support Catheter518-034518-0342022-02-22
00813132029357Quick-Cross Support Catheter518-035518-0352022-02-22
00813132029364Quick-Cross Support Catheter518-036518-0362022-02-22
00813132029371Quick-Cross Support Catheter518-037518-0372022-02-22
00813132029388Quick-Cross Support Catheter518-038518-0382022-02-22
00813132029395Quick-Cross Support Catheter518-065518-0652022-02-22
00813132029401Quick-Cross Support Catheter518-066518-0662022-02-22
00813132029418Quick-Cross Extreme Support Catheter518-084518-0842023-10-04
00813132029425Quick-Cross Extreme Support Catheter518-086518-0862023-10-04
00813132029432Quick-Cross Extreme Support Catheter518-088518-0882023-10-04
00813132029449Quick-Cross Extreme Support Catheter518-090518-0902023-10-04
00813132029456Quick-Cross Extreme Support Catheter518-092518-0922023-10-04
00813132029470Quick-Cross Extreme Support Catheter518-078518-0782023-10-04
00813132029487Quick-Cross Extreme Support Catheter518-080518-0802023-10-04
00813132029494Quick-Cross Extreme Support Catheter518-082518-0822023-10-04
00813132029517Quick-Cross Select Support Catheter518-085518-0852023-10-04
00813132029524Quick-Cross Select Support Catheter518-087518-0872023-10-04
00813132029531Quick-Cross Select Support Catheter518-089518-0892023-10-04

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