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FDA 510(k)

CENTRI-SAFE(TM) VALVE

K-Number: K921500 · 1992-09-15

ApplicantCardio Systems, Inc.
Decision Date1992-09-15
Product CodeMJJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CENTRI-SAFE(TM) VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Systems, Inc.. It received FDA 510(k) clearance on 1992-09-15 under 510(k) number K921500. The device is classified under product code MJJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRI-SAFE(TM) VALVE?

CENTRI-SAFE(TM) VALVE is a medical device that received FDA 510(k) clearance on 1992-09-15. The listed applicant is Cardio Systems, Inc.. The 510(k) number is K921500.

When did CENTRI-SAFE(TM) VALVE receive FDA 510(k) clearance?

CENTRI-SAFE(TM) VALVE received FDA 510(k) clearance on 1992-09-15, under 510(k) number K921500.

Who is the listed applicant for CENTRI-SAFE(TM) VALVE?

The FDA 510(k) record lists Cardio Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTRI-SAFE(TM) VALVE?

The FDA product code for CENTRI-SAFE(TM) VALVE is MJJ.

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Other records listing Cardio 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.

K131092STEALTH 360 ORBITAL PAD SYSTEMK081944MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEMK972022ZAK-2000K934689LOW AIR LOSS MATTRESS, MODIFICATIONK882177ADD-ON TO CRITICAL PATIENT CARE BEDK852736BAYLOR RAPID AUTOTRANSFUSION SYSTEM

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Related Devices (Code: MJJ)

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.

K182442MiniGuard Arterial Safety ValveQuest Medical, Inc.K0012453T L. V. CONTROL VALVE3t Medical Systems, LLCK992785IBC FLOGUARD, MODEL 6050International Biophysics Corp.K982406COBE VACUUM RELIEF CHECK VALVECobe Cardiovascular, Inc.K960937SUCTION SAFETY DEVICER D Intl.K922781FLOW CONROL VALVEAmerican Omni Medical, Inc.

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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