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FDA 510(k)

VENOJECT AUTOSEP

K-Number: K792587 · 1980-01-17

ApplicantKimble-Terumo, Inc.
Decision Date1980-01-17
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VENOJECT AUTOSEP is the device name listed in this FDA 510(k) record. The listed applicant is Kimble-Terumo, Inc.. It received FDA 510(k) clearance on 1980-01-17 under 510(k) number K792587. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENOJECT AUTOSEP?

VENOJECT AUTOSEP is a medical device that received FDA 510(k) clearance on 1980-01-17. The listed applicant is Kimble-Terumo, Inc.. The 510(k) number is K792587.

When did VENOJECT AUTOSEP receive FDA 510(k) clearance?

VENOJECT AUTOSEP received FDA 510(k) clearance on 1980-01-17, under 510(k) number K792587.

Who is the listed applicant for VENOJECT AUTOSEP?

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

What is the FDA product code for VENOJECT AUTOSEP?

The FDA product code for VENOJECT AUTOSEP is JKA.

Related Clinical Trials

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Other records listing Kimble-Terumo, 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.

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Related Devices (Code: JKA)

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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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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