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FDA 510(k)

ADVANCED CARDIOVASCULAR BALLOON DILATA

K-Number: K842556 · 1984-08-10

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1984-08-10
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADVANCED CARDIOVASCULAR BALLOON DILATA is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 1984-08-10 under 510(k) number K842556. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANCED CARDIOVASCULAR BALLOON DILATA?

ADVANCED CARDIOVASCULAR BALLOON DILATA is a medical device that received FDA 510(k) clearance on 1984-08-10. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K842556.

When did ADVANCED CARDIOVASCULAR BALLOON DILATA receive FDA 510(k) clearance?

ADVANCED CARDIOVASCULAR BALLOON DILATA received FDA 510(k) clearance on 1984-08-10, under 510(k) number K842556.

Who is the listed applicant for ADVANCED CARDIOVASCULAR BALLOON DILATA?

The FDA 510(k) record lists Advanced Cardiovascular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANCED CARDIOVASCULAR BALLOON DILATA?

The FDA product code for ADVANCED CARDIOVASCULAR BALLOON DILATA is LIT.

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Other records listing Advanced Cardiovascular Systems, Inc. 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.

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