FDA 510(k)

DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET

K-Number: K861390 · 1986-07-17

Decision Date1986-07-17

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1986-07-17 under 510(k) number K861390. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET?

DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET is a medical device that received FDA 510(k) clearance on 1986-07-17. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K861390.

When did DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET receive FDA 510(k) clearance?

DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET received FDA 510(k) clearance on 1986-07-17, under 510(k) number K861390.

Who is the listed applicant for DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET?

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

What is the FDA product code for DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET?

The FDA product code for DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET is FMI.

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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.