FDA 510(k)

PERCLUDER DL OCCLUDING BALLOON

K-Number: K832386 · 1983-10-19

Decision Date1983-10-19

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PERCLUDER DL OCCLUDING BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1983-10-19 under 510(k) number K832386. 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 PERCLUDER DL OCCLUDING BALLOON?

PERCLUDER DL OCCLUDING BALLOON is a medical device that received FDA 510(k) clearance on 1983-10-19. The listed applicant is Datascope Corp.. The 510(k) number is K832386.

When did PERCLUDER DL OCCLUDING BALLOON receive FDA 510(k) clearance?

PERCLUDER DL OCCLUDING BALLOON received FDA 510(k) clearance on 1983-10-19, under 510(k) number K832386.

Who is the listed applicant for PERCLUDER DL OCCLUDING BALLOON?

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

What is the FDA product code for PERCLUDER DL OCCLUDING BALLOON?

The FDA product code for PERCLUDER DL OCCLUDING BALLOON 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.