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
00810024671885CPS Locator 3D, Small Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671892CPS Locator 3D, Medium Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671908CPS Locator 3D, Large Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671915CPS Locator 3D, Medium, Extra Long Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671922CPS Locator 3D, Large, Extra Long Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2026-07-10
008537990079308F Base Camp System 2.0 90cmROUTE 92 MEDICALDQY2026-07-08
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.ITX2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.ITX2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.IYO2026-06-24
10801902218732ARROWTELEFLEX INCORPORATEDDQY2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.ITX2026-06-23
00841517112646L15-4FUJIFILM SONOSITE, INC.IYO2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.ITX2026-06-22
00841517112639L12-3FUJIFILM SONOSITE, INC.IYO2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10