TVC Insight XB™ TVC-C195-32

GUDID 00857595006227

Insight XB™ Catheter Kit The TVC Insight XB™ Extended Bandwidth™ NIRS-IVUS Catheter Kit (TVC-C195-32) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™(TVC-MC9, TVC-MC9i, and properly configured TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and 50 MHz Extended Bandwidth ultrasonics for simultaneous acquisition of vessel structure and plaque composition— a single catheter, a single pullback, two sets of data. The Insight XB catheter features a 50MHz Extended Bandwidth IVUS transducer and durable hydrophilic coating for improved delivery. 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.

INFRAREDX, INC.

Intravascular ultrasound imaging catheter, single-use

• Primary Device ID: 00857595006227
• NIH Device Record Key: 3428ffdc-ced6-47e6-ac40-cae3b4e8996a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TVC Insight XB™
• Version Model Number: TVC-C195-32
• Catalog Number: TVC-C195-32
• Company DUNS: 124065421
• Company Name: INFRAREDX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com
• Phone: 888-680-7339
• Email: customerservice@infraredx.com

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
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• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
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• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
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• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
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• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
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• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
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• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
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• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857595006227 [Primary]
GS1	00857595006326 [Package]; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141682

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-09-15

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