LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER— 510(k) K880605

Name: FDA 510(k) clearance K880605
Creator: U.S. Food and Drug Administration
Published: 1988-05-26

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K880605 for LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER, Substantially Equivalent on 1988-05-26. Applicant: Miles Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code FPB
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1988-02-12
Decision date: 1988-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkeley, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FPB

product code FPB

Other: 1
Total: 1

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.