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FDA 510(k)

PICC Maximal Barrier Nursing Kit

K-Number: K163452 · 2017-02-03

Decision Date2017-02-03
Product CodeLJS
Advisory CommitteeHO
DecisionUnknown

Device Summary

PICC Maximal Barrier Nursing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Navilyst Medical, Inc.. It received FDA 510(k) clearance on 2017-02-03 under 510(k) number K163452. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the PICC Maximal Barrier Nursing Kit?

PICC Maximal Barrier Nursing Kit is a medical device that received FDA 510(k) clearance on 2017-02-03. The listed applicant is Navilyst Medical, Inc.. The 510(k) number is K163452.

When did PICC Maximal Barrier Nursing Kit receive FDA 510(k) clearance?

PICC Maximal Barrier Nursing Kit received FDA 510(k) clearance on 2017-02-03, under 510(k) number K163452.

Who is the listed applicant for PICC Maximal Barrier Nursing Kit?

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

What is the FDA product code for PICC Maximal Barrier Nursing Kit?

The FDA product code for PICC Maximal Barrier Nursing Kit is LJS.

Other records listing Navilyst Medical, Inc. 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.

Related Devices (Code: LJS)

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.

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.