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FDA 510(k)

UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE

K-Number: K860168 · 1986-02-19

ApplicantUniversal Medical Instrument Corp.
Decision Date1986-02-19
Product Code
DecisionSubstantially Equivalent

Device Summary

UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Universal Medical Instrument Corp.. It received FDA 510(k) clearance on 1986-02-19 under 510(k) number K860168. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE?

UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE is a medical device that received FDA 510(k) clearance on 1986-02-19. The listed applicant is Universal Medical Instrument Corp.. The 510(k) number is K860168.

When did UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE receive FDA 510(k) clearance?

UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE received FDA 510(k) clearance on 1986-02-19, under 510(k) number K860168.

Who is the listed applicant for UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE?

The FDA 510(k) record lists Universal Medical Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

Related Clinical Trials

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Other records listing Universal Medical Instrument Corp. 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.

K962180CATH SEALK935077CATH-SEALK897128UMI BRAIDED CATHETER CONNECTORK881796UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLEK863178UMI STEERABLE TORQUE GUIDE WIREK861984UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO

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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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