PTI Intra-Art Internal Mammary Artery Cannula Kit

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

510(k) Number

K894684 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Anastomart(Tm) Coronary Bypass Graft Markers/Modif

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  FDA 510(k) K922025 Active Cleared 22 Sep 1992

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  FDA 510(k) K874927 Active Cleared 29 Jan 1988

• Pti Intra-Artr Reusable Coronary Artery Probe

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  FDA 510(k) K901531 Active Cleared 20 Jun 1990

• Pti Intra-Art(Tm) Ansari Saphenous Vein Holder

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• Pti Anastomark Flexible Coronary Bypass Graft

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  FDA 510(k) K905067 Active Cleared 18 Mar 1991

• Pti Heart-Lift(Tm) Cardiac Elevator (Sterile)

  Class I

  FDA 510(k) K883135 Active Cleared 26 Sep 1988

See all devices from Pioneering Technologies, Inc. →

• What is the PTI Intra-Art Internal Mammary Artery Cannula Kit used for?

  This kit is designed specifically for cannulation of the internal mammary artery during cardiopulmonary bypass procedures, such as coronary artery bypass grafting (CABG). It provides controlled perfusion and blood flow through the artery, ensuring adequate oxygenation and circulation during surgery. The cannula facilitates arterial access, which is critical for maintaining patient stability during complex cardiovascular interventions.

• Is the PTI Intra-Art Cannula Kit sterile and single-use?

  Yes, the PTI Intra-Art Cannula Kit is supplied as a sterile, single-use device. Sterility is essential in surgical settings to prevent infection, and single-use ensures patient safety by eliminating cross-contamination risks. Always follow standard sterile medical device protocols when handling and storing the kit.

• How should the PTI Intra-Art Cannula Kit be stored before use?

  Prior to use, the kit must be stored in a clean, dry environment to maintain its integrity and sterility. Avoid exposure to moisture, extreme temperatures, or direct sunlight. Adhering to these storage guidelines ensures the device remains ready for use in operating room settings when needed.

• Can the cannula in this kit be reused?

  No, the cannula in the PTI Intra-Art Cannula Kit is non-reusable. Reusing vascular cannulas poses significant risks, including infection, clotting, and device failure, which could compromise patient safety. Each kit is designed for one-time use only, in compliance with medical device regulations.

• What regulatory approval does the PTI Intra-Art Cannula Kit hold?

  The PTI Intra-Art Cannula Kit holds FDA 510(k) clearance (K894684) under the Special Controls regulation 870.4210, classified as a Class II medical device. This clearance confirms that the device meets FDA requirements for safety and effectiveness as a vascular cannula and tubing assembly for cardiopulmonary bypass procedures. Always verify current regulatory status with the manufacturer.