FDA.reportPublic FDA data

SLT IVUS P1 Cart

Primary DI
00850045446048
Brand
SLT IVUS P1 Cart
Company
Provisio Medical, Inc.
Model
CART01
Catalog number
CART01
Device description
See LBL-0998, SLT IVUS P1 System Manual
Published
2024-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
OBJCatheter, Ultrasound, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
OBJCatheter, Ultrasound, IntravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233948000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233948000Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.2024-04-23OBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045446048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045446048008500454460488500454460480850045446048

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
858-524-3901info@provisiomedical.com

Regulatory Flags#

DUNS number
015877254
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850045446000SLT IVUS P1 Pulser Receiver UnitPRU001PRU0012024-05-24
00850045446024SLT IVUS Support Crossing CatheterP018150P0181502024-05-24
00850045446031SLT IVUS P1 Display UnitDU0001DU00012024-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
00841436126311Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.ITX2025-11-19
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00841436102797eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2023-05-08
00841436121583VirtuTRAX Instrument NavigatorCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2022-10-28
B201CGCORE170Clear Guide CORECLEAR GUIDE MEDICAL, INC.IYO2022-10-07
B201CGOHM0Clear Guide Optical HeadCLEAR GUIDE MEDICAL, INC.IYO2022-10-07
00841436120234Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2021-11-20
00841436120241Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2021-11-20
00841436113694Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2021-06-23
00841436114271Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2021-06-23
00841436118811Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2021-01-22
00841436118828Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2021-01-22
00841436119948Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2021-01-22
00841436119955Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2021-01-22
00841436119986Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2021-01-22
00841436119993Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2021-01-22
00841436120166Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2021-01-22
00841436120173Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2021-01-22