EUPALAMUS DEFLECTABLE STYLET, MODEL 01545— 510(k) K002534

Name: FDA 510(k) clearance K002534
Creator: U.S. Food and Drug Administration
Published: 2000-10-18

Substantially Equivalent

Eupalamus, LLC

FDA 510(k) clearance K002534 for EUPALAMUS DEFLECTABLE STYLET, MODEL 01545, Substantially Equivalent on 2000-10-18. Applicant: Eupalamus, LLC. Device class: 2.

Clearance details

Applicant: Eupalamus, LLC
Product code: Code DRB
Device class: Class 2
Regulation: 21 CFR 870.1380
Advisory panel: Cardiovascular
Date received: 2000-08-16
Decision date: 2000-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brentwood, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRB

view all

K220280 — Arrow Stiffening Stylet2022-08-30
K191469 — Biotronik Stylets2019-08-01
K182660 — GaltTWS2019-05-30
K170298 — Liberator Beacon Tip Locking Stylet2017-10-18
K142116 — LLD EZ2014-08-12

Adverse events under product code DRB

product code DRB

Death: 36
Injury: 562
Total: 598

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.