FDA.reportPublic FDA data

Revolution Rotational Imaging Catheter

Primary DI
00184360000358
Brand
Revolution Rotational Imaging Catheter
Company
Philips Image Guided Therapy Corporation
Model
89000
Catalog number
89000
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
OBJCatheter, Ultrasound, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBJCatheter, Ultrasound, IntravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050995000
K080891000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050995000REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETERVolcano Corporation2005-06-20OBJ
K080891000REVOLUTION 45MHZ IVUS IMAGING CATHETERVolcano Corporation2008-05-12OBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00184360000358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00184360000358001843600003581843600003580184360000358

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.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845225013011ICE PIMPhilips Image Guided Therapy CorporationOBJ2026-07-30
10801902219333ARROWTELEFLEX INCORPORATEDOBJ2026-07-30
10801902194654ARROWTELEFLEX INCORPORATEDOBJ2026-07-29
16975345061102Disposable Intracardiac Echocardiography CatheterJiangsu Tingsn Technology Co., Ltd.OBJ2026-01-31
00884838112988Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838124929Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838127098Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838127111EPIQ 5 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838127128EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
04056869957708AcuNav CRYSTAL G Ultrasound CatheterSIEMENS MEDICAL SOLUTIONS USA, INC.OBJ2025-11-21
05415067053190ViewFlex™IRVINE BIOMEDICAL, INC.OBJ2025-11-21
00845225003319Visions PV .014P RX Digital IVUS CatheterPhilips Image Guided Therapy CorporationOBJ2025-09-24
00845225003364Eagle Eye Platinum RX Digital IVUS CatheterPhilips Image Guided Therapy CorporationOBJ2025-09-24
00845225003371Eagle Eye Platinum ST RX Digital IVUS CatheterPhilips Image Guided Therapy CorporationOBJ2025-09-24
10841716103602ACIST Kodama® Coronary Imaging CatheterACIST MEDICAL SYSTEMS, INC.OBJ2025-08-14
10846835026559NUVISION NAV Ultrasound CatheterBiosense Webster IncOBJ2025-07-02
10846835026566NUVISION Ultrasound CatheterBiosense Webster IncOBJ2025-07-02
00884838126893EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2025-06-23
00884838126909Affiniti CVx Diagnostic Ultrasound System Philips Ultrasound LLCOBJ2025-06-23
00884838126923EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2025-06-23
00884838126930EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2025-06-23
00884838126947Affiniti CVx Diagnostic Ultrasound System Circular EditionPhilips Ultrasound LLCOBJ2025-06-23
00850044399147NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOBJ2025-05-21
00850044399222NES Reprocessed Eagle Eye Platinum Short Tip StrykerNORTH EAST SCIENTIFIC INCOBJ2025-05-21
00850044399239NES Reprocessed .035 Stryker CatheterNORTH EAST SCIENTIFIC INCOBJ2025-05-21
00850044399178NES Reprocessed Visions PV .018 Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOBJ2025-05-19
00845225012854ICE PIMPhilips Image Guided Therapy CorporationOBJ2025-03-24
07613327664096Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
07613327664102Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
07613327664119Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11