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FDA 510(k)

ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm

K-Number: K170958 · 2017-08-29

ApplicantTricol Biomedical, Inc.
Decision Date2017-08-29
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm is the device name listed in this FDA 510(k) record. The listed applicant is Tricol Biomedical, Inc.. It received FDA 510(k) clearance on 2017-08-29 under 510(k) number K170958. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm?

ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm is a medical device that received FDA 510(k) clearance on 2017-08-29. The listed applicant is Tricol Biomedical, Inc.. The 510(k) number is K170958.

When did ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm receive FDA 510(k) clearance?

ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm received FDA 510(k) clearance on 2017-08-29, under 510(k) number K170958.

Who is the listed applicant for ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm?

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

What is the FDA product code for ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm?

The FDA product code for ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm is DXC.

Related Devices (Code: DXC)

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Official Source

View on FDA Database →

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

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