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

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..

Clearance details

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

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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.