Elgiloy Stylet

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K770243 ↗

FDA Product Code

DRR

Device Class

Class II

Regulation

21 CFR Part 870.2050

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acuity Universal Cutter

  Class II

  FDA 510(k) K080154 Active Cleared 20 Mar 2008

• Pacemaker Programmer #2010

  Class III

  FDA 510(k) K811217 Active Cleared 20 Jul 1981

• Microthin-Pii Bipolar Pulse Gen. #0623

  Class III

  FDA 510(k) K803034 Active Cleared 22 Dec 1980

• Astra 2, 3, 4 and 6: Chip Revision

  Not classified

  FDA 510(k) K863000 Active Cleared 19 Aug 1986

• Command Ultra I Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K831161 Active Cleared 15 Jun 1983

• Micro Thin-PII, #0523

  Class III

  FDA 510(k) K802353 Active Cleared 22 Dec 1980

See all devices from Cardiac Pacemakers, Inc. →