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FDA 510(k)

ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE

K-Number: K875269 · 1988-02-12

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1988-02-12
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE 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 1988-02-12 under 510(k) number K875269. 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 ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE?

ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE is a medical device that received FDA 510(k) clearance on 1988-02-12. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K875269.

When did ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE receive FDA 510(k) clearance?

ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE received FDA 510(k) clearance on 1988-02-12, under 510(k) number K875269.

Who is the listed applicant for ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE?

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 ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE?

The FDA product code for ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE is DQY.

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Other records listing Advanced Cardiovascular Systems, Inc. as applicant

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.

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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.

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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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