CMS IV FILTERS— 510(k) K896333

Substantially Equivalent

Churchill Medical Systems, Inc.

FDA 510(k) clearance K896333 for CMS IV FILTERS, Substantially Equivalent on 1990-01-11. Applicant: Churchill Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant
Churchill Medical Systems, Inc.
Product code
Code FPB
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Horsham, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FPB

product code FPB
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.