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FDA 510(k)

ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES

K-Number: K854261 · 1985-12-04

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1985-12-04
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES 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 1985-12-04 under 510(k) number K854261. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES?

ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES is a medical device that received FDA 510(k) clearance on 1985-12-04. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K854261.

When did ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES receive FDA 510(k) clearance?

ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES received FDA 510(k) clearance on 1985-12-04, under 510(k) number K854261.

Who is the listed applicant for ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES?

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 HEMOSTATIC VALVES?

The FDA product code for ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES is DTL.

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Other records listing Advanced Cardiovascular Systems, Inc. as applicant

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Related Devices (Code: DTL)

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.

K131124COLIGNJilin Coronado Medical , Ltd.K123448AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVEMedtronic, Inc.K122811CONNECTOR COMPONENTS WITH BALANCE BIOSURFACEMedtronic, Inc.K122301GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVEVascular Solutions Zerusa , Ltd.K120069MEDLINE STOPCOCK AND MANIFOLDMedline Industries, Inc.K113148E-PASSSynexmed(Shenzhen)Company Limited

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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