Scanlan Endarsector

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K841521 ↗

FDA Product Code

DWX

Device Class

Class II

Regulation

21 CFR Part 870.4875

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Scanlan Vascu-Statt

  Class I

  FDA 510(k) K802829 Active Cleared 15 Jan 1981

• Surgical Instrument Demagnetizer

  Not classified

  FDA 510(k) K841086 Active Cleared 24 Apr 1984

• Scanlan/Taheri Valvulotome

  Class II

  FDA 510(k) K911184 Active Cleared 18 Feb 1992

• Scanlan(R) Thoracoscopic Scissors, Clamp, Forceps, Needle Holder

  Class II

  FDA 510(k) K945474 Active Cleared 5 Dec 1994

• Vascu-Statt Approximator

  Class I

  FDA 510(k) K823694 Active Cleared 7 Jan 1983

• Scanlan Tunneler, Sheath & Tip

  Class I

  FDA 510(k) K851825 Active Cleared 12 Jul 1985

See all devices from Scanlan Intl., Inc. →

• What is the Scanlan Endarsector used for?

  The Scanlan Endarsector is a cardiovascular device designed for use in intraluminal arterial procedures.

• Is the device sterile and intended for single use?

  Yes, the device is supplied sterile and is intended for single use.

• Is the device MRI safe?

  Yes, the Scanlan Endarsector is MRI safe.

• What sizes are available for the device?

  The device is available in multiple sizes.