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FDA 510(k)

CORONARY INFUSION CATHETER W/SIDEHOLES

K-Number: K850353 · 1985-04-10

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1985-04-10
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORONARY INFUSION CATHETER W/SIDEHOLES 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 1985-04-10 under 510(k) number K850353. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORONARY INFUSION CATHETER W/SIDEHOLES?

CORONARY INFUSION CATHETER W/SIDEHOLES is a medical device that received FDA 510(k) clearance on 1985-04-10. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K850353.

When did CORONARY INFUSION CATHETER W/SIDEHOLES receive FDA 510(k) clearance?

CORONARY INFUSION CATHETER W/SIDEHOLES received FDA 510(k) clearance on 1985-04-10, under 510(k) number K850353.

Who is the listed applicant for CORONARY INFUSION CATHETER W/SIDEHOLES?

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 CORONARY INFUSION CATHETER W/SIDEHOLES?

The FDA product code for CORONARY INFUSION CATHETER W/SIDEHOLES is DQY.

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Other records listing Advanced Cardiovascular Systems, Inc. as applicant

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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