MTS CATHETER ADAPTER FOR GUIDANCE ENTRY— 510(k) K791797

Substantially Equivalent

Medical Testing System, Inc.

FDA 510(k) clearance K791797 for MTS CATHETER ADAPTER FOR GUIDANCE ENTRY, Substantially Equivalent on 1979-10-11. Applicant: Medical Testing System, Inc..

Clearance details

Applicant: Medical Testing System, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1979-09-14
Decision date: 1979-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.