FDA 510(k)

SOFTOUCH GUIDING CATHETER

K-Number: K902953 · 1990-09-28

Decision Date1990-09-28

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SOFTOUCH GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical. It received FDA 510(k) clearance on 1990-09-28 under 510(k) number K902953. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFTOUCH GUIDING CATHETER?

SOFTOUCH GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 1990-09-28. The listed applicant is Mallinckrodt Medical. The 510(k) number is K902953.

When did SOFTOUCH GUIDING CATHETER receive FDA 510(k) clearance?

SOFTOUCH GUIDING CATHETER received FDA 510(k) clearance on 1990-09-28, under 510(k) number K902953.

Who is the listed applicant for SOFTOUCH GUIDING CATHETER?

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

What is the FDA product code for SOFTOUCH GUIDING CATHETER?

The FDA product code for SOFTOUCH GUIDING CATHETER is DQO.

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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.