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FDA 510(k)

THERATEK GROUP EXCHANGE CATHETER

K-Number: K904680 · 1990-12-27

ApplicantDow Corning Wright
Decision Date1990-12-27
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THERATEK GROUP EXCHANGE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Dow Corning Wright. It received FDA 510(k) clearance on 1990-12-27 under 510(k) number K904680. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERATEK GROUP EXCHANGE CATHETER?

THERATEK GROUP EXCHANGE CATHETER is a medical device that received FDA 510(k) clearance on 1990-12-27. The listed applicant is Dow Corning Wright. The 510(k) number is K904680.

When did THERATEK GROUP EXCHANGE CATHETER receive FDA 510(k) clearance?

THERATEK GROUP EXCHANGE CATHETER received FDA 510(k) clearance on 1990-12-27, under 510(k) number K904680.

Who is the listed applicant for THERATEK GROUP EXCHANGE CATHETER?

The FDA 510(k) record lists Dow Corning Wright as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERATEK GROUP EXCHANGE CATHETER?

The FDA product code for THERATEK GROUP EXCHANGE CATHETER is MCW.

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Other records listing Dow Corning Wright as applicant

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Related Devices (Code: MCW)

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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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