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FDA 510(k)

TVC Imaging System, TVC Catheter

K-Number: K163345 · 2017-06-21

ApplicantInfraredx, Inc.
Decision Date2017-06-21
Product CodeOGZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TVC Imaging System, TVC Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Infraredx, Inc.. It received FDA 510(k) clearance on 2017-06-21 under 510(k) number K163345. The device is classified under product code OGZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TVC Imaging System, TVC Catheter?

TVC Imaging System, TVC Catheter is a medical device that received FDA 510(k) clearance on 2017-06-21. The listed applicant is Infraredx, Inc.. The 510(k) number is K163345.

When did TVC Imaging System, TVC Catheter receive FDA 510(k) clearance?

TVC Imaging System, TVC Catheter received FDA 510(k) clearance on 2017-06-21, under 510(k) number K163345.

Who is the listed applicant for TVC Imaging System, TVC Catheter?

The FDA 510(k) record lists Infraredx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TVC Imaging System, TVC Catheter?

The FDA product code for TVC Imaging System, TVC Catheter is OGZ.

Other records listing Infraredx, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241576Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )K213303Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42K183599Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter

Related Devices (Code: OGZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241576Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )Infraredx, Inc.K183599Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging CatheterInfraredx, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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