BD ChloraShield IV Dressing with CHG Antimicrobial— 510(k) K170407

Substantially Equivalent

Avery Dennison Belgie Bvba

FDA 510(k) clearance K170407 for BD ChloraShield IV Dressing with CHG Antimicrobial, Substantially Equivalent on 2017-07-17. Applicant: Avery Dennison Belgie Bvba.

Clearance details

Applicant: Avery Dennison Belgie Bvba
Product code: Code FRO
Advisory panel: Unknown
Date received: 2017-02-10
Decision date: 2017-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Turnhout, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.