SILICONE FLOW-DIRECTED THERMODILUTION CATHETER— 510(k) K893435

Substantially Equivalent

Cathlab Corp.

FDA 510(k) clearance K893435 for SILICONE FLOW-DIRECTED THERMODILUTION CATHETER, Substantially Equivalent on 1989-09-26. Applicant: Cathlab Corp..

Clearance details

Applicant: Cathlab Corp.
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 1989-05-02
Decision date: 1989-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

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Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.