ENDOTRACHEAL TUBE GUIDE OR INTUBATION STYLETTE— 510(k) K854632

Substantially Equivalent

Respiratory Support Products, Inc.

FDA 510(k) clearance K854632 for ENDOTRACHEAL TUBE GUIDE OR INTUBATION STYLETTE, Substantially Equivalent on 1986-01-03. Applicant: Respiratory Support Products, Inc..

Clearance details

Applicant: Respiratory Support Products, Inc.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1985-11-21
Decision date: 1986-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

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Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.