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FDA 510(k)

SWIVEL COUPLER

K-Number: K863205 · 1986-10-02

ApplicantVenmill Swivel, Co.
Decision Date1986-10-02
Product CodeBYJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SWIVEL COUPLER is the device name listed in this FDA 510(k) record. The listed applicant is Venmill Swivel, Co.. It received FDA 510(k) clearance on 1986-10-02 under 510(k) number K863205. The device is classified under product code BYJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWIVEL COUPLER?

SWIVEL COUPLER is a medical device that received FDA 510(k) clearance on 1986-10-02. The listed applicant is Venmill Swivel, Co.. The 510(k) number is K863205.

When did SWIVEL COUPLER receive FDA 510(k) clearance?

SWIVEL COUPLER received FDA 510(k) clearance on 1986-10-02, under 510(k) number K863205.

Who is the listed applicant for SWIVEL COUPLER?

The FDA 510(k) record lists Venmill Swivel, Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SWIVEL COUPLER?

The FDA product code for SWIVEL COUPLER is BYJ.

Related Clinical Trials

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.

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Related Devices (Code: BYJ)

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.

K130068DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)Essex Industries, Inc. D/B/A Essex Cryogenics of MK113767MOUNTED MEDICAL OXYGEN SYSTEMEssex Industries, Inc.K103324PRECISION LIQUID OXYGEN SYSTEMPrecision Medical, Inc.K101272MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3Essex Industries, Inc.K081779GOLOX-93Respironics, Inc.K080023MODIFICATION TO: SPIRITCaire, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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