MODIFIED ADULT CRICOTHYROIDOTOMY KIT— 510(k) K885139

Substantially Equivalent

Pertrach

FDA 510(k) clearance K885139 for MODIFIED ADULT CRICOTHYROIDOTOMY KIT, Substantially Equivalent on 1989-05-25. Applicant: Pertrach.

Clearance details

Applicant: Pertrach
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1988-12-15
Decision date: 1989-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, WV, US

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Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.