K944729

Substantially Equivalent

STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE

Applicant: Coast Medical, Inc.
Product code: BSR
Advisory panel: Anesthesiology
Date received: 1994-09-26
Decision date: 1994-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Adverse events under product code BSR

product code BSR

Death: 2
Other: 1
Total: 3

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.