Robicsek–Pruitt Aortic Balloon Occlusion Kit

• • Terminated Z-0219-06 FDA Unclassified (pre-2012) ·initiated 17 May 2005

  LeMaitre Vascular is recalling certain lots of its Pruitt Aortic Occlusion Catheters due to a packaging defect which could compromise product sterility.

Full name

The Robicsek - Pruitt Aortic Balloon Occlusion Kit

510(k) Number

K872090 ↗

FDA Product Code

DQT

Device Class

Class II

Regulation

21 CFR Part 870.1370

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pruitt Safety Occlusion Catheter

  Class II

  FDA 510(k) K960422 Active Cleared 7 Aug 1996

• Godat Uterine Manipulator Injector

  Class II

  FDA 510(k) K935023 Active Cleared 4 Jan 1995

• Pruitt Embolectomy/Irrigation Catheter (Modified)

  Class II

  FDA 510(k) K864062 Active Cleared 6 Jan 1987

• Modified Pruitt Irrigation & Occlusion Catheter Open recall

  Class II

  FDA 510(k) K880231 Active Cleared 25 May 1988

• Ideas Dual Port

  Class II

  FDA 510(k) K962751 Active Cleared 30 Sep 1996

• Modified Info Inserts for Pruitt Irri.-Occlu. Cath

  Class II

  FDA 510(k) K872154 Active Cleared 3 Aug 1987

See all devices from Ideas For Medicine, Inc. →

• What is the Robicsek–Pruitt Aortic Balloon Occlusion Kit used for?

  This kit is designed for selective vascular occlusion during surgical procedures. By inflating the balloon at the catheter tip, it temporarily blocks blood flow in the aorta or its branches, enabling controlled surgical access or isolation of specific anatomical regions. This is particularly useful in cardiovascular surgeries where precise blood flow management is critical.

• Is the Robicsek–Pruitt Aortic Balloon Occlusion Kit sterile and single-use?

  Yes, the kit is supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and maintaining sterility throughout the procedure. The FDA 510(k) clearance (K872090) explicitly indicates its single-use designation.

• Can this device be used with MRI equipment?

  No, the Robicsek–Pruitt Aortic Balloon Occlusion Kit is not MRI-compatible. This limitation is important to note when planning surgical workflows, as MRI use during or after the procedure could pose risks to the device or the patient.

• What storage and handling protocols should be followed for this kit?

  The kit must be stored and handled according to standard sterile medical device protocols. Since it is sterile and single-use, it should be kept in its original packaging until immediately before use, and aseptic techniques must be maintained throughout the procedure to prevent contamination.

• Are there different sizes or models available for this occlusion kit?

  The regulatory data does not specify any size variations for the Robicsek–Pruitt Aortic Balloon Occlusion Kit. It is designed as a single standardized device for general use in aortic occlusion procedures, ensuring consistency in performance and application.