FDA 510(k)

DIAGNOSTIC INTRAVASCULAR CATHETERS

K-Number: K853182 · 1986-01-15

Decision Date1986-01-15

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC INTRAVASCULAR CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1986-01-15 under 510(k) number K853182. 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 DIAGNOSTIC INTRAVASCULAR CATHETERS?

DIAGNOSTIC INTRAVASCULAR CATHETERS is a medical device that received FDA 510(k) clearance on 1986-01-15. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K853182.

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

DIAGNOSTIC INTRAVASCULAR CATHETERS received FDA 510(k) clearance on 1986-01-15, under 510(k) number K853182.

Who is the listed applicant for DIAGNOSTIC INTRAVASCULAR CATHETERS?

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

What is the FDA product code for DIAGNOSTIC INTRAVASCULAR CATHETERS?

The FDA product code for DIAGNOSTIC INTRAVASCULAR CATHETERS 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.