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FDA 510(k)

COMFORT-SET* I.V. CATHETER PLACEMENT UNIT.

K-Number: K862130 · 1986-08-14

ApplicantMenlo Care, Inc.
Decision Date1986-08-14
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMFORT-SET* I.V. CATHETER PLACEMENT UNIT. is the device name listed in this FDA 510(k) record. The listed applicant is Menlo Care, Inc.. It received FDA 510(k) clearance on 1986-08-14 under 510(k) number K862130. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORT-SET* I.V. CATHETER PLACEMENT UNIT.?

COMFORT-SET* I.V. CATHETER PLACEMENT UNIT. is a medical device that received FDA 510(k) clearance on 1986-08-14. The listed applicant is Menlo Care, Inc.. The 510(k) number is K862130.

When did COMFORT-SET* I.V. CATHETER PLACEMENT UNIT. receive FDA 510(k) clearance?

COMFORT-SET* I.V. CATHETER PLACEMENT UNIT. received FDA 510(k) clearance on 1986-08-14, under 510(k) number K862130.

Who is the listed applicant for COMFORT-SET* I.V. CATHETER PLACEMENT UNIT.?

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

What is the FDA product code for COMFORT-SET* I.V. CATHETER PLACEMENT UNIT.?

The FDA product code for COMFORT-SET* I.V. CATHETER PLACEMENT UNIT. is FOZ.

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Other records listing Menlo Care, Inc. as applicant

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Related Devices (Code: FOZ)

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

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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