Churchill Inter-Cardiac Sucker

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

510(k) Number

K872043 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Churchill Haber Point Needle Admin. Set

  Class II

  FDA 510(k) K850420 Active Cleared 24 Apr 1985

• Churchill-Hs Suspended Non-Vented IV Set

  Class II

  FDA 510(k) K854630 Active Cleared 10 Dec 1985

• Churchill-H Extension Tube

  Class II

  FDA 510(k) K854629 Active Cleared 10 Dec 1985

• Churchill Blood Administration Set

  Class II

  FDA 510(k) K864441 Active Cleared 20 Jan 1987

• Churchill-H Vented IV Set W/Metering Chambers

  Class II

  FDA 510(k) K871732 Active Cleared 15 Jun 1987

• Blood Gas Sampler Kit

  Class II

  FDA 510(k) K850958 Active Cleared 10 Apr 1985

See all devices from Churchill Corp. →

• What is the Churchill Inter-Cardiac Sucker used for?

  The Churchill Inter-Cardiac Sucker is a catheter, cannula, and tubing device intended for use in vascular and cardiopulmonary bypass procedures, specifically for cardiovascular applications as indicated in its FDA 510(k) clearance.

• Is the Churchill Inter-Cardiac Sucker sterile or non-sterile, and is it reusable?

  The device is supplied as a non-sterile, reusable device for general hospital use in cardiovascular settings, meaning it must be cleaned and sterilized by the healthcare facility before each use.

• What regulatory pathway was used for the Churchill Inter-Cardiac Sucker, and when was it cleared?

  The device received traditional 510(k) clearance (K872043) from the FDA on September 30, 1987, based on a determination of substantial equivalence to a predicate device.