510(k) K030570— BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE

Substantially Equivalent

Portex , Ltd.

Clearance details

Applicant: Portex , Ltd.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 2003-02-24
Decision date: 2003-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hyth, Kent, GB

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.