Search Results

The CardioFocus Deflectable Sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The HeartLight® Deflectable Sheath is a sterile, disposable device which provides a conduit for catheter introduction into the vasculature and into the chambers of the heart. The Deflectable Sheath is able to move its distal section in one direction in a single plane and is activated by a rotating knob at the front of the device handle. The deflection of the sheath and the torquing of the device allow the distal end of the sheath to be positioned at the ostium of pulmonary veins.

The CardioFocus Diode Laser System is intended for the delivery of 980nm laser light to soft tissue in contact or noncontact mode during surgical procedures including via endoscopes, introducers or catheters. Indications include the incision, excision, dissection, vaporization, ablation or coagulation of soft tissue.

The CardioFocus Diode Laser Ablation System is a generator designed for the delivery of 980nm laser light and may be used in conjunction with surgical treatment for hemostasis, incision, ablation, coagulation and vaporization of tissue as required by the clinician. The instrument includes a diode laser module as the therapeutic energy source, as well as an internal thermal safety system for monitoring and disabling laser power output.

The Malleable Surgical Lightstic™ 180 is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), in the contact or non-contact mode in both open or closed surgical procedures (with or without handpiece). Its intended use is identical to the current Surgical Lightstic™ 180 (K011988). Coagulation of Cardiac Tissue

Malleable Surgical Lightstic™ 180

The Surgical Lightstic" 180 is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), in the contact or non-contact mode in both open or closed surgical procedures (with or without handpiece). The Surgical Lightstic™ 180 is indicated for use in laser medicine and surgery with 980-1064 nm wavelength laser energy in the following surgical specialties: general surgery, cardiothoracic surgery(recommended 980nm), plastic surgery and dermatology. Expanded for: Coagulation of Cardiac Tissue These are additional indications to the already cleared indications for market release in K993834.

Not Found

The Surgical Lightstic" 180 is intended to be used as a surgical instrument for coagulation of soft tissue in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), and coagulation of soft tissue in the contact mode in both open or closed surgical procedures (with or without handpiece). The Surgical Lightstic™ 180 is indicated for use in medicine and surgery with 980 - 1064 nm wavelength laser energy in the following surgical specialties: General Surgery, Plastic Surgery, and Dermatology.

Not Found