FDA 510(k)

SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER

K-Number: K931479 · 1993-10-06

Decision Date1993-10-06

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SOFTOUCH DIAGNOSTIC INTRAVASCULAR 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 1993-10-06 under 510(k) number K931479. 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 DIAGNOSTIC INTRAVASCULAR CATHETER?

SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER is a medical device that received FDA 510(k) clearance on 1993-10-06. The listed applicant is Mallinckrodt Medical. The 510(k) number is K931479.

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

SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER received FDA 510(k) clearance on 1993-10-06, under 510(k) number K931479.

Who is the listed applicant for SOFTOUCH DIAGNOSTIC INTRAVASCULAR 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 DIAGNOSTIC INTRAVASCULAR CATHETER?

The FDA product code for SOFTOUCH DIAGNOSTIC INTRAVASCULAR 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.