DUAL FLOW NEEDLE— 510(k) K832136

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K832136 for DUAL FLOW NEEDLE, Substantially Equivalent on 1983-10-14. Applicant: Travenol Laboratories, S.A.. Device class: 2.

Clearance details

Applicant
Travenol Laboratories, S.A.
Product code
Code FIE
Device class
Class 2
Regulation
21 CFR 876.5540
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FIE

product code FIE
Death
2
Total
2

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.