PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE— 510(k) K901920

Substantially Equivalent

Primecare, Inc.

FDA 510(k) clearance K901920 for PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE, Substantially Equivalent on 1990-08-17. Applicant: Primecare, Inc..

Clearance details

Applicant: Primecare, Inc.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1990-04-30
Decision date: 1990-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, 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.