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FDA 510(k)

Arrow Epidural Catheter Kit

K-Number: K161075 · 2016-10-04

ApplicantTeleflexmedical, Inc.
Decision Date2016-10-04
Product CodeCAZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Arrow Epidural Catheter Kit is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2016-10-04 under 510(k) number K161075. The device is classified under product code CAZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arrow Epidural Catheter Kit?

Arrow Epidural Catheter Kit is a medical device that received FDA 510(k) clearance on 2016-10-04. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K161075.

When did Arrow Epidural Catheter Kit receive FDA 510(k) clearance?

Arrow Epidural Catheter Kit received FDA 510(k) clearance on 2016-10-04, under 510(k) number K161075.

Who is the listed applicant for Arrow Epidural Catheter Kit?

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

What is the FDA product code for Arrow Epidural Catheter Kit?

The FDA product code for Arrow Epidural Catheter Kit is CAZ.

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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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