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FDA 510(k)

COBE VACUUM RELIEF CHECK VALVE

K-Number: K982406 · 1998-10-07

ApplicantCobe Cardiovascular, Inc.
Decision Date1998-10-07
Product CodeMJJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE VACUUM RELIEF CHECK VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Cardiovascular, Inc.. It received FDA 510(k) clearance on 1998-10-07 under 510(k) number K982406. 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 COBE VACUUM RELIEF CHECK VALVE?

COBE VACUUM RELIEF CHECK VALVE is a medical device that received FDA 510(k) clearance on 1998-10-07. The listed applicant is Cobe Cardiovascular, Inc.. The 510(k) number is K982406.

When did COBE VACUUM RELIEF CHECK VALVE receive FDA 510(k) clearance?

COBE VACUUM RELIEF CHECK VALVE received FDA 510(k) clearance on 1998-10-07, under 510(k) number K982406.

Who is the listed applicant for COBE VACUUM RELIEF CHECK VALVE?

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

What is the FDA product code for COBE VACUUM RELIEF CHECK VALVE?

The FDA product code for COBE VACUUM RELIEF CHECK VALVE is MJJ.

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Other records listing Cobe Cardiovascular, 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.

K050111SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAGK042473COBE ANGEL WHOLE BLOOD SEPARATION SYSTEMK040184DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTERK033641SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800K030462COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700K021830SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA 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.K960937SUCTION SAFETY DEVICER D Intl.K922781FLOW CONROL VALVEAmerican Omni Medical, Inc.K922356FLOW CONTROL VALVE, CAT. NO. ACV-38American 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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