FDA 510(k)

OPTIBOLUS

K-Number: K031339 · 2003-07-11

ApplicantMallinckrodt Inc., Liebel-Flarsheim Business

Decision Date2003-07-11

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OPTIBOLUS is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Inc., Liebel-Flarsheim Business. It received FDA 510(k) clearance on 2003-07-11 under 510(k) number K031339. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIBOLUS?

OPTIBOLUS is a medical device that received FDA 510(k) clearance on 2003-07-11. The listed applicant is Mallinckrodt Inc., Liebel-Flarsheim Business. The 510(k) number is K031339.

When did OPTIBOLUS receive FDA 510(k) clearance?

OPTIBOLUS received FDA 510(k) clearance on 2003-07-11, under 510(k) number K031339.

Who is the listed applicant for OPTIBOLUS?

The FDA 510(k) record lists Mallinckrodt Inc., Liebel-Flarsheim Business as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIBOLUS?

The FDA product code for OPTIBOLUS is DXT.

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Other records listing Mallinckrodt Inc., Liebel-Flarsheim Business as applicant

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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.