NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet— 510(k) K172208

Substantially Equivalent

Nevap, Inc.

FDA 510(k) clearance K172208 for NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet, Substantially Equivalent on 2018-02-16. Applicant: Nevap, Inc..

Clearance details

Applicant: Nevap, Inc.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 2017-07-24
Decision date: 2018-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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.