FDA.reportPublic FDA data

SLT IVUS P1 Pulser Receiver Unit

Primary DI
00850045446000
Brand
SLT IVUS P1 Pulser Receiver Unit
Company
Provisio Medical, Inc.
Model
PRU001
Catalog number
PRU001
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
00850045446000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045446000008500454460008500454460000850045446000

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-15 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
015877254
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850045446024SLT IVUS Support Crossing CatheterP018150P0181502024-05-24
00850045446031SLT IVUS P1 Display UnitDU0001DU00012024-05-24
00850045446048SLT IVUS P1 CartCART01CART012024-05-24

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Primary DI, Brand, Company table
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00810024671922CPS Locator 3D, Large, Extra Long Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
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