Pul, Monary Artery Vent Catheter

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K845046 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Percutaneous Guidewire Placement Syringe 50505

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• What is the primary purpose of the Pulmonary Artery Vent Catheter during surgery?

  The Pulmonary Artery Vent Catheter is designed specifically for use during cardiopulmonary bypass procedures. Its main purpose is to facilitate drainage and decompression of the left ventricle by venting blood from the pulmonary artery, which helps maintain stable hemodynamic conditions throughout the surgery.

• Is this device intended for reuse or is it single-use only?

  The Pulmonary Artery Vent Catheter is explicitly intended for single-use in controlled surgical environments like operating rooms. This ensures patient safety and reduces the risk of contamination or device failure associated with reuse.

• What sizes are available for the Pulmonary Artery Vent Catheter, and how are they referenced?

  The device is available in specific sizes, with the 16 Fr model referenced as VT-89416. This sizing is tailored for use in cardiovascular surgical settings where precise catheter placement is critical.

• How is the Pulmonary Artery Vent Catheter supplied, and what does this mean for clinical workflow?

  The catheter is supplied sterile, which means it is pre-packaged and ready for immediate use in the operating room without additional sterilization steps. This streamlines workflow and ensures sterility before clinical application.

• What regulatory pathway was followed for this device, and how does it relate to its use in cardiology?

  The Pulmonary Artery Vent Catheter received FDA 510(k) clearance (K845046) under the classification 870.4210, confirming it as a Class II medical device. The clearance was determined through the Cardiovascular (CV) Advisory Committee, reflecting its specialized role in cardiopulmonary bypass procedures. This regulatory status ensures compliance with safety and performance standards for use in cardiovascular surgery.