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FDA 510(k)

ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO

K-Number: K853746 · 1985-10-21

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1985-10-21
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO 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 1985-10-21 under 510(k) number K853746. 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 SYSTEMS DOUBLE LUMEN BALLO?

ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO is a medical device that received FDA 510(k) clearance on 1985-10-21. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K853746.

When did ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO receive FDA 510(k) clearance?

ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO received FDA 510(k) clearance on 1985-10-21, under 510(k) number K853746.

Who is the listed applicant for ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO?

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 SYSTEMS DOUBLE LUMEN BALLO?

The FDA product code for ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO is LIT.

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Other records listing Advanced Cardiovascular Systems, Inc. as applicant

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Related Devices (Code: 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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