Catheter, Arterial Embolectomy

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K770714 ↗

FDA Product Code

DXE

Device Class

Class II

Regulation

21 CFR Part 870.5150

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Foam Nose

  Class I

  FDA 510(k) K840399 Active Cleared 16 Mar 1984

• Isotonic Diluent

  Class I

  FDA 510(k) K781008 Active Cleared 28 Jun 1978

• Hi-Lo Temp Thermocouple to Thermister Adaptor

  Class II

  FDA 510(k) K844201 Active Cleared 4 Mar 1985

• Glucose Reagent (O-Toluidine)

  Class II

  FDA 510(k) K771314 Active Cleared 3 Aug 1977

• Ria Quant C-Peptide Kit

  Class I

  FDA 510(k) K812689 Active Cleared 6 Oct 1981

• Hi-Lo Temp(R) Model 8700 Patient Temp Monitor

  Class II

  FDA 510(k) K874568 Active Cleared 6 Jan 1988

See all devices from Mallinckrodt Critical Care →

• What is the Arterial Embolectomy Catheter used for?

  The Arterial Embolectomy Catheter is designed for use in cardiovascular applications to remove arterial emboli. It is a Class II medical device specifically created for embolectomy procedures.

• Is this catheter reusable or single-use?

  This arterial embolectomy catheter is supplied as a single-use device and should not be reused. It requires sterile handling and is stored at room temperature.

• What is the regulatory status of this device?

  The device received FDA 510(k) clearance with number K770714 on April 27, 1977, and is regulated under 870.5150 with special controls for Class II devices.

• Is this catheter MRI compatible?

  No, the Arterial Embolectomy Catheter is not MRI compatible. It should only be used according to its intended purpose and specifications.