RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS— 510(k) K884435

Substantially Equivalent

Clinical Connections, Inc.

FDA 510(k) clearance K884435 for RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS, Substantially Equivalent on 1988-11-08. Applicant: Clinical Connections, Inc.. Device class: 2.

Clearance details

Applicant
Clinical Connections, Inc.
Product code
Code FMG
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Orrville, OH, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FMG

product code FMG
Death
14
Malfunction
3,433
Other
1
Total
3,448

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.