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Eupalamus Deflectable Stylet, Model 01545

by Eupalamus, LLC 510(k)

Active United States

510(k) K002534

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK002534 Date18 Oct 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DRB
Device Class
Class II
Regulation
21 CFR Part 870.1380
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent