TVC Insight™ - Insight Catheter™ Kit The TVC Insight Catheter™ - INFRAREDX, INC.

Duns Number:124065421

Device Description: Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single use, disposa Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer.Indications for Use: 1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

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More Product Details

Catalog Number

TVC-C195-20

Brand Name

TVC Insight™

Version/Model Number

TVC-C195-20

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123108,K123108

Product Code Details

Product Code

IYO

Product Code Name

System, Imaging, Pulsed Echo, Ultrasonic

Device Record Status

Public Device Record Key

565abbe7-5f5e-4713-8b08-7ff43e15c342

Public Version Date

March 21, 2019

Public Version Number

5

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

00857595006302

Quantity per Package

5

Contains DI Package

00857595006203

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"INFRAREDX, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13