DeviceClearance

TUBING CONNECTORS EC-2XXX SERIES— 510(k) K833322

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K833322 for TUBING CONNECTORS EC-2XXX SERIES, Substantially Equivalent on 1983-12-16. Applicant: Gish Biomedical, Inc.. Device class: 2.

Clearance details

Applicant
Gish Biomedical, Inc.
Product code
Code DTL
Device class
Class 2
Regulation
21 CFR 870.4290
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DTL

product code DTL
Malfunction
770
Total
770

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 →

Recalls naming K833322

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K833322.

Data sourced from openFDA. This site is unofficial and independent of the FDA.