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FDA 510(k)

TCA 5R / 5S

K-Number: K070123 · 2007-03-09

ApplicantDornier Medtech America, Inc.
Decision Date2007-03-09
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TCA 5R / 5S is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2007-03-09 under 510(k) number K070123. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TCA 5R / 5S?

TCA 5R / 5S is a medical device that received FDA 510(k) clearance on 2007-03-09. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K070123.

When did TCA 5R / 5S receive FDA 510(k) clearance?

TCA 5R / 5S received FDA 510(k) clearance on 2007-03-09, under 510(k) number K070123.

Who is the listed applicant for TCA 5R / 5S?

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

What is the FDA product code for TCA 5R / 5S?

The FDA product code for TCA 5R / 5S is OWB.

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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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