FDA 510(k)

CIVCO LATEX ULTRASOUND SHEATHS

K-Number: K895614 · 1989-12-14

ApplicantCIVCO Medical Instruments Co., Inc.

Decision Date1989-12-14

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CIVCO LATEX ULTRASOUND SHEATHS is the device name listed in this FDA 510(k) record. The listed applicant is CIVCO Medical Instruments Co., Inc.. It received FDA 510(k) clearance on 1989-12-14 under 510(k) number K895614. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIVCO LATEX ULTRASOUND SHEATHS?

CIVCO LATEX ULTRASOUND SHEATHS is a medical device that received FDA 510(k) clearance on 1989-12-14. The listed applicant is CIVCO Medical Instruments Co., Inc.. The 510(k) number is K895614.

When did CIVCO LATEX ULTRASOUND SHEATHS receive FDA 510(k) clearance?

CIVCO LATEX ULTRASOUND SHEATHS received FDA 510(k) clearance on 1989-12-14, under 510(k) number K895614.

Who is the listed applicant for CIVCO LATEX ULTRASOUND SHEATHS?

The FDA 510(k) record lists CIVCO Medical Instruments Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CIVCO LATEX ULTRASOUND SHEATHS?

The FDA product code for CIVCO LATEX ULTRASOUND SHEATHS is IYO.

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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.