Transvenous Balloon Tipped(Flow Directed) Temp. Pa

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

510(k) Number

K844752 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Endomyocardial Biopsy Device

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• Heparin Coat Tran Ballo Tip Temp Pac Electrode

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  FDA 510(k) K852797 Active Cleared 16 Sep 1985

See all devices from Mainsfield Scientific, Inc. →

• What clinical settings is this catheter primarily used in, and what does it measure?

  This device is designed for short-term hemodynamic monitoring in intensive care units (ICUs) and cardiac care units. It measures central venous pressure and pulmonary artery pressure by using a balloon-tipped, flow-directed design that follows blood flow dynamics for accurate placement, reducing reliance on fluoroscopy.

• Is this catheter reusable or intended for single-use, and how should it be handled?

  The catheter is supplied sterile and intended for single-use only. Due to its sterile packaging, it requires aseptic handling during insertion and must be properly disposed of after use to maintain infection control standards.

• Does this device require fluoroscopy for proper placement, and why?

  The flow-directed design of this catheter is engineered to follow natural blood flow dynamics, which often allows for accurate placement without fluoroscopy in many clinical scenarios. This reduces the need for X-ray guidance while still ensuring correct positioning in the pulmonary artery.

• What storage conditions should be followed for this device?

  The manufacturer recommends storing this catheter in sterile, dry conditions as specified in their guidelines. Since it is supplied sterile and single-use, it should remain unopened until ready for immediate clinical use to preserve sterility.

• What regulatory pathway does this device follow, and how does that affect its use?

  This device follows the FDA 510(k) clearance pathway (K844752) under the classification for permanent pacemaker electrodes (DTB 300xx series). The clearance ensures it meets U.S. regulatory standards for cardiovascular monitoring devices, though clinical use remains guided by physician judgment and institutional protocols.