FDA 510(k)

ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)

K-Number: K861483 · 1986-05-15

Decision Date1986-05-15

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY) 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 1986-05-15 under 510(k) number K861483. 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 ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)?

ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY) is a medical device that received FDA 510(k) clearance on 1986-05-15. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K861483.

When did ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY) receive FDA 510(k) clearance?

ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY) received FDA 510(k) clearance on 1986-05-15, under 510(k) number K861483.

Who is the listed applicant for ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)?

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 ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)?

The FDA product code for ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY) is DQO.

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Other records listing Mallinckrodt Critical Care as applicant

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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.