Search Results
Found 6 results
510(k) Data Aggregation
K Number
K081457Device Name
ATRILAZE LASER ABLATION SYSTEM
Manufacturer
MEDICALCV, INC.
Date Cleared
2008-08-08
(77 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MEDICALCV, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATRILAZE™ Surgical Ablation System is indicated for delivery of 810nm, 1064nm or 1083nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, excision, dissection, vaporization, ablation, or coagulation of soft tissue.
The ATRILAZE™ Surgical Ablation System Accessories are intended for use in the support of the delivery of laser light to soft tissue to include cardiac tissue during surgical procedures.
Device Description
The ATRILAZE™ Surgical Ablation System consists of a Laser Energy Generator, system cart, fluid delivery pump, fluid delivery tubing set and a fixed or flexible surgical ablation wand of various lengths. The wand is an intraoperative, sterile, single-use device designed to apply laser energy to cardiac tissue. The fluid delivery tubing set is a single-use device having a sterile fluid path designed for the delivery of sterile saline solution to the wand tip. The fluid delivery tubing may be provided together with the wand or as an accessory device. The fluid delivery pump and laser energy generator are sold separately. The wand includes a ridged metallic shaft or a flexible shaft of various lengths, and is equipped with a 905 SMA connector cable which attaches to the laser energy generator output connector. The emitted laser energy is directed toward the target tissue from the end of the optical fiber which rides within the flexible track.
Ask a Question
K Number
K061489Device Name
ATRILAZE MI SURGICAL ABLATION SYSTEM
Manufacturer
MEDICALCV, INC.
Date Cleared
2007-03-16
(289 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MEDICALCV, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedicalCV SOLAR™ Surgical Ablation System is indicated for delivery of 810nm or 1064nm laser light to soft tissue, under direct visualization, during surgical procedures. Indications include the ablation, or coagulation of soft tissue.
Device Description
The Solar™ Surgical Ablation System consists of a Laser Energy Generator, a Reciprocator Control unit, a fluid delivery tubing set and a flexible surgical ablation track. The Solar™ Orbital Track is an intraoperative, sterile, single-use device designed to apply laser energy to tissue. The fluid delivery tubing set is a single-use device having a sterile fluid path designed for the delivery of sterile saline solution to the ablation catheter. The Reciprocator Control unit is a motion generating device housing the fluid delivery pump and provides the means of monitoring the ablation process parameters. The laser energy Generator and Reciprocator Control Unit are sold separately. The Solar™ Orbital Track includes a ridged metallic shaft, a flexible track, and a guide lead and is equipped with a 905 SMA connector cable which attaches to the laser energy generator output connector. The emitted laser energy is directed toward the target tissue from the end of the optical fiber which rides within the flexible track.
Ask a Question
K Number
K060680Device Name
ATRILAZE SURGICAL ABLATION SYSTEM
Manufacturer
MEDICALCV, INC.
Date Cleared
2006-04-11
(27 days)
Product Code
GEX, OCL
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MEDICALCV, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medical CV Atrilaze™ Surgical Ablation System is indicated for delivery of 810nm or 1064nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, dissection, vaporization, ablation, or coagulation of soft tissue.
Device Description
The Altrilaze Surgical Ablation System consists of a generator designed for the delivery of 810nm or 1064nm laser light and a hand held fiber optic light delivery device (probe) fitted with a standard SMA 905 connector at the proximal end. The system may be used in conjunction with surgical treatment for hemostasis, incision, coagulation and vaporization of tissue as required by the clinician.
Ask a Question
K Number
K052495Device Name
ATRILAZE MALLEABLE ABLATION PROBE
Manufacturer
MEDICALCV, INC.
Date Cleared
2005-10-11
(29 days)
Product Code
GEX, OLC
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MEDICALCV, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedicalCV, Inc. Atrilaze™ Surgical Ablation System is Indicated for delivery of 810nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, excision, dissection, vaporization, ablation, or coagulation of soft tissue.
Device Description
The Altrilaze Malleable S-2 Disposable Probe is used with the Atrilaze™ Surgical Ablation System which consists of a generator designed for the delivery of 8 l 0nm laser light and a hand held fiber optic light delivery device (probe) fitted with a standard SMA 905 connector at the proximal end. The system may be used in conjunction with surgical treatment for hemostasis, incision, ablation, coagulation and vaporization of tissue as required by the clinician
Ask a Question
K Number
K040744Device Name
ATRILAZE SOFT TISSUE ABLATION SYSTEM
Manufacturer
MEDICALCV, INC.
Date Cleared
2004-11-30
(252 days)
Product Code
GEX, OCL
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MEDICALCV, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedicalCV, Inc. Atrilaze™ Soft Tissue Ablation System is indicated for delivery of 810nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, dissection, vaporization, ablation, or coagulation of soft tissue.
Device Description
The Altrilaze Soft Tissue Ablation System consists of a generator designed for the delivery of 810nm laser light and a hand held fiber optic light delivery device (probe) fitted with a standard SMA 905 connector at the proximal rond. The system may be used in conjunction with surgical treatment for hemostasis, incision, ablation, coaeglytion and vaporization of tissue as required by the clinician.
Ask a Question
K Number
K033685Device Name
NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000
Manufacturer
MEDICALCV, INC.
Date Cleared
2004-08-03
(253 days)
Product Code
KRH
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
MEDICALCV, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedicalCV, Inc. Northrup Universal Annuloplasty System is indicated as a reinforcement for repair of the human cardiac mitral or tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.
Device Description
The Northrup Universal Annuloplasty System consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral or tricuspid position. A complete set of instrumentation is available separately to properly size the annulus.
Ask a Question
Page 1 of 1