SLT IVUS Support Crossing Catheter

Basic Information

• Brand Name: SLT IVUS Support Crossing Catheter
• Primary DI: 00850045446024
• Version / Model: P018150
• Catalog Number: P018150
• Company Name: Provisio Medical, Inc.
• Labeler DUNS: 015877254
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-24
• Public Version: 1
• Public Version Date: 2024-06-03
• Public Version Status: New
• Public Device Record Key: 9a1c95e9-9e70-4cd0-bf41-043c21034c61

Device Description

The SLT IVUS Support Crossing Catheters are over-the-wire intravascular ultrasound catheters with a digital ultrasound transducer array at the distal end that also functions as support crossing catheter.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OJB	Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate	Orthopedic	888.3060	2
DQY	Catheter, Percutaneous	Cardiovascular	870.1250	2
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44141	Intravascular ultrasound imaging catheter, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850045446024	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K233948	000