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FDA 510(k)

LOW PROFILE STEERABLE BALLOON DILATION

K-Number: K843880 · 1984-11-27

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1984-11-27
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LOW PROFILE STEERABLE BALLOON DILATION 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 1984-11-27 under 510(k) number K843880. 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 LOW PROFILE STEERABLE BALLOON DILATION?

LOW PROFILE STEERABLE BALLOON DILATION is a medical device that received FDA 510(k) clearance on 1984-11-27. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K843880.

When did LOW PROFILE STEERABLE BALLOON DILATION receive FDA 510(k) clearance?

LOW PROFILE STEERABLE BALLOON DILATION received FDA 510(k) clearance on 1984-11-27, under 510(k) number K843880.

Who is the listed applicant for LOW PROFILE STEERABLE BALLOON DILATION?

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 LOW PROFILE STEERABLE BALLOON DILATION?

The FDA product code for LOW PROFILE STEERABLE BALLOON DILATION is LIT.

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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.

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