CATHETER, SINGLE PUNCTURE Y— 510(k) K770482

Substantially Equivalent

Mdl Medical Device Laboratories, Inc.

FDA 510(k) clearance K770482 for CATHETER, SINGLE PUNCTURE Y, Substantially Equivalent on 1977-04-15. Applicant: Mdl Medical Device Laboratories, Inc..

Clearance details

Applicant: Mdl Medical Device Laboratories, Inc.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1977-03-14
Decision date: 1977-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.