FDA 510(k)

BD ChloraShield IV Dressing with CHG Antimicrobial

K-Number: K170407 · 2017-07-17

Decision Date2017-07-17

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

BD ChloraShield IV Dressing with CHG Antimicrobial is the device name listed in this FDA 510(k) record. The listed applicant is Avery Dennison Belgie Bvba. It received FDA 510(k) clearance on 2017-07-17 under 510(k) number K170407. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD ChloraShield IV Dressing with CHG Antimicrobial?

BD ChloraShield IV Dressing with CHG Antimicrobial is a medical device that received FDA 510(k) clearance on 2017-07-17. The listed applicant is Avery Dennison Belgie Bvba. The 510(k) number is K170407.

When did BD ChloraShield IV Dressing with CHG Antimicrobial receive FDA 510(k) clearance?

BD ChloraShield IV Dressing with CHG Antimicrobial received FDA 510(k) clearance on 2017-07-17, under 510(k) number K170407.

Who is the listed applicant for BD ChloraShield IV Dressing with CHG Antimicrobial?

The FDA 510(k) record lists Avery Dennison Belgie Bvba as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD ChloraShield IV Dressing with CHG Antimicrobial?

The FDA product code for BD ChloraShield IV Dressing with CHG Antimicrobial is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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.

NCT05741866Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs)COMPLETED

Other records listing Avery Dennison Belgie Bvba as applicant

K202208BeneHold Surgical Incise Drape with CHG antimicrobial

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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.