MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION— 510(k) K913817

Name: FDA 510(k) clearance K913817
Creator: U.S. Food and Drug Administration
Published: 1992-06-11

Substantially Equivalent

Synectics-Dantec

FDA 510(k) clearance K913817 for MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION, Substantially Equivalent on 1992-06-11. Applicant: Synectics-Dantec. Device class: 1.

Clearance details

Applicant: Synectics-Dantec
Product code: Code FFT
Device class: Class 1
Regulation: 21 CFR 876.1400
Advisory panel: Gastroenterology, Urology
Date received: 1991-08-26
Decision date: 1992-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sweden, SE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FFT

product code FFT

Injury: 595
Malfunction: 2,175
Other: 1
Total: 2,771

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.