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FDA 510(k)

LOW PROFILE STEERABLE BALLOON DILATA

K-Number: K831403 · 1983-06-08

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1983-06-08
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LOW PROFILE STEERABLE 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 1983-06-08 under 510(k) number K831403. 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 DILATA?

LOW PROFILE STEERABLE BALLOON DILATA is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K831403.

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

LOW PROFILE STEERABLE BALLOON DILATA received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831403.

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

The FDA product code for LOW PROFILE STEERABLE BALLOON DILATA 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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