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FDA 510(k)

LEFT VENTRICULAR VENT VALVE MODEL NO. GLV

K-Number: K862540 · 1986-08-29

ApplicantGish Biomedical, Inc.
Decision Date1986-08-29
Product CodeDWD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEFT VENTRICULAR VENT VALVE MODEL NO. GLV is the device name listed in this FDA 510(k) record. The listed applicant is Gish Biomedical, Inc.. It received FDA 510(k) clearance on 1986-08-29 under 510(k) number K862540. The device is classified under product code DWD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEFT VENTRICULAR VENT VALVE MODEL NO. GLV?

LEFT VENTRICULAR VENT VALVE MODEL NO. GLV is a medical device that received FDA 510(k) clearance on 1986-08-29. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K862540.

When did LEFT VENTRICULAR VENT VALVE MODEL NO. GLV receive FDA 510(k) clearance?

LEFT VENTRICULAR VENT VALVE MODEL NO. GLV received FDA 510(k) clearance on 1986-08-29, under 510(k) number K862540.

Who is the listed applicant for LEFT VENTRICULAR VENT VALVE MODEL NO. GLV?

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

What is the FDA product code for LEFT VENTRICULAR VENT VALVE MODEL NO. GLV?

The FDA product code for LEFT VENTRICULAR VENT VALVE MODEL NO. GLV is DWD.

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Other records listing Gish Biomedical, Inc. as applicant

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Related Devices (Code: DWD)

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.

K992657IBC VRV, MODEL 1350International Biophysics Corp.K920077NIKKISO NK PUMPInternational Medical Products, Inc.K915480B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.Bd Becton Dickinson Vacutainer Systems PreanalyticK915482B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PTBd Becton Dickinson Vacutainer Systems PreanalyticK915481B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINTBd Becton Dickinson Vacutainer Systems PreanalyticK905311DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.Baxter Bentley Laboratories, 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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