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FDA 510(k)

CENTRAL VENOUS ACCESS CATHETER CVAC

K-Number: K832396 · 1983-08-31

ApplicantGish Biomedical, Inc.
Decision Date1983-08-31
Product CodeDOY
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CENTRAL VENOUS ACCESS CATHETER CVAC 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 1983-08-31 under 510(k) number K832396. The device is classified under product code DOY. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRAL VENOUS ACCESS CATHETER CVAC?

CENTRAL VENOUS ACCESS CATHETER CVAC is a medical device that received FDA 510(k) clearance on 1983-08-31. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K832396.

When did CENTRAL VENOUS ACCESS CATHETER CVAC receive FDA 510(k) clearance?

CENTRAL VENOUS ACCESS CATHETER CVAC received FDA 510(k) clearance on 1983-08-31, under 510(k) number K832396.

Who is the listed applicant for CENTRAL VENOUS ACCESS CATHETER CVAC?

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 CENTRAL VENOUS ACCESS CATHETER CVAC?

The FDA product code for CENTRAL VENOUS ACCESS CATHETER CVAC is DOY.

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Other records listing Gish Biomedical, 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.

K090449MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LTK090450MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LTK091062MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730K083131MEDOS HILITE RESERVOIR, MODEL: 4030K082403MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LTK082082GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING

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Related Devices (Code: DOY)

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.

K910154USCI ILLUMEN-8 8F PTCA GUIDING CATHETERC.R. Bard, Inc.K831239WALRUS PERCUTANEOUS INTRODUCER SETMedical Parameters, Inc.K831191VASCULAR CATHETERMedrad, Inc.K831188CONNECTOR TUBEMedrad, 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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