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510(k) Data Aggregation
K Number
K010974Device Name
RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET
Manufacturer
CALIFORNIA MEDICAL LABORATORIES, INC.
Date Cleared
2001-06-18
(77 days)
Product Code
DWF
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
CALIFORNIA MEDICAL LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002019Device Name
RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET
Manufacturer
CALIFORNIA MEDICAL LABORATORIES, INC.
Date Cleared
2001-03-30
(270 days)
Product Code
DWF
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
CALIFORNIA MEDICAL LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000830Device Name
CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE
Manufacturer
CALIFORNIA MEDICAL LABORATORIES, INC.
Date Cleared
2000-09-07
(177 days)
Product Code
DWF
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
CALIFORNIA MEDICAL LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993818Device Name
ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE
Manufacturer
CALIFORNIA MEDICAL LABORATORIES, INC.
Date Cleared
2000-02-08
(90 days)
Product Code
DWF, NOV
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
CALIFORNIA MEDICAL LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Antegrade/Retrograde Perfusion Adapter is indicated for use to deliver cardioplegia solution to either the aortic root or coronary sinus. The Antegrade/Retrograde Perfusion Adapter with Pressure Line is indicated for use to deliver cardioplegia solution to either the aortic root or coronary sinus while continually monitoring the pressure of the coronary sinus.
Device Description
The Antegrade/Retrogarde Perfusion Adapters are designed to deliver cardioplegia solution to either the coronary sinus or aortic root by the turn of a stopcock and are available with or without a pressure monitoring line. The model with a pressure monitoring line allows for simultaneous monitoring of the coronary sinus pressure while administering cardioplegia solution to either the coronary sinus or aortic root.
In general, a red color-coded tubing with a standard male luer connects to the aortic root cannula's infusion port while a blue color-coded tubing with a standard male luer connects to the coronary sinus cannula's infusion port for delivery of cardioplegia solution. The model provided with a pressure monitoring line is connected to the pressure monitoring outlet of the coronary sinus cannula at one end and the other end is connected to a transducer via a female luerlock connector. An optional male luer-lock swivel adapter is also supplied for this connection. The cardioplegia inlet tubing, which is white color-coded in the pressure monitoring line model, connects to the cardioplegia administration line. The adapter also has a base plate, which allows for either suturing or clamping of the stopcock to the surgical drape.
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K Number
K982891Device Name
CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
Manufacturer
CALIFORNIA MEDICAL LABORATORIES, INC.
Date Cleared
1998-09-30
(44 days)
Product Code
DTS
Regulation Number
870.4420Why did this record match?
Applicant Name (Manufacturer) :
CALIFORNIA MEDICAL LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Standard and Small Rigid Tip Suction Wands are designed to remove excess fluid from the surgical field.
The Standard and Small Rigid Tip Suction Wands are indicated for use to remove excess fluid from the surgical field.
Device Description
The Standard and Small Rigid Tip Suction Wands are designed to remove excess fluid from the surgical field.
The Standard Rigid Tip Suction Wand consists of an angled Stainless Steel suction wand bonded to a rigid, fluted style suction tip at the distal end and a ¼" barbed connector at the proximal end both of which are made of ABS. The stainless steel wand has a lightweight plastic handle made of medical grade ABS material.
The Small Rigid Tip Suction Wand is manufactured in a similar manner and consisting of the same materials as the Standard Rigid Tip Suction Wand.
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K Number
K981601Device Name
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
Manufacturer
CALIFORNIA MEDICAL LABORATORIES, INC.
Date Cleared
1998-07-28
(85 days)
Product Code
DWF
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
CALIFORNIA MEDICAL LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Malleable Vent Catheter is intended for use during cardiopulmonary bypass Surgery to vent/drain the left ventricle.
Device Description
The Malleable Vent Catheter is designed to vent/drain the left ventricular during coronary artery bypass surgery.
It consists of soft polyviny] chloride (PVC) tubing with a radius tip and vent holes 3.5 cm along the distal tip. The soft PVC tubing consists of two lumens; one large lumen for venting/drainage and one smaller lumen which encapsulates the stainless steel wire. The encapuslated stainless steel wire enables preshaping of the catheter prior to insertion and support during catheter placement. The proximal end of the catheter contains a rigid PVC connector and depth markings along the farge lumen.
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K Number
K972503Device Name
CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
Manufacturer
CALIFORNIA MEDICAL LABORATORIES, INC.
Date Cleared
1997-08-26
(54 days)
Product Code
DWF
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
CALIFORNIA MEDICAL LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The vessel cannula will be supplied with a wing or without a wing, with or without a check valve to deliver cardioplegia solution to the heart during cardiopulmonary bypass surgery and to perfuse a vein graft or access the patency of the vessel to be used as a graft during cardiopulmonary bypass surgery.
The aortic root cannula is designed to deliver cardioplegia solution during cardiopulmonary bypass surgery and aspirate air from the aorta at the end of the cardiopulmonary bypass surgery. The aortic root cannula with vent line is designed to deliver cardioplegia solution and vent the heart during cardiopulmonary bypass surgery.
The cardioplegia "Y" perfusion adapter is designed for use with the aortic root cannula and vessel cannula to deliver cardioplegia solution during cardiopulmonary bypass surgery. The cardioplegia "Y" recirculation adapter is designed for recirculating of cardioplegia solution during cardiopulmonary bypass surgery. The cardioplegia straight adapter is designed for use during cardiopulmonary bypass surgery for connecting a cannula or catheter to an administration or vent line. The cardioplegia "Y" venting adapter is designed for use during cardiopulmonary bypass surgery to deliver cardioplegia solution and vent the left heart.
Device Description
The Vessel Cannula is indicated for use in the delivery of cardiopleqia solution during cardiopulmonary bypass surgery or to perfuse a vein graft or access the patency in a harvested vein which will be used for a graft. The Vessel Cannula is a flexible, tapered, polyvinyl chloride tube with a soft distal tip. The distal tip is composed of two sizes of anchor hubs (3mm distal-3.6mm proximal) designed to accommodate vessels of various diameters. The proximal female luer-lock is designed to securely connect with a standard cardioplegia delivery line. The cannula is available with or without wings and with or without a check valve.
The Aortic Root Cannula is designed to deliver cardioplegia solution during cardiopulmonary bypass surgery. The cannula consists of flexible polyvinyl chloride tubing with a movable sew ring attached to a soft distal tip. The distal tip has a flange with four suture holes. An introducer needle assembly is provided to facilitate entry into the aorta.
The Cardioplegia Straight Adapter is indicated during cardiopulmonary bypass surgery for connecting a cannula or catheter to an administration and or a vent line. The straight adapter consists of flexible polyvinyl tubing, and connecting adapters in a straight configuration.
The Cardioplegia "Y" Venting Adapter is designed to be used in conjunction with cardiopulmonary bypass surgery to deliver cardioplegia solution, and venting the left heart. It may also be used as an extension line by itself. The adapter consists of flexible polyvinyl chloride tubing, "Y" connector, tubing clamps, and connecting adapters in a "Y" configuration.
The Cardioplegia "Y" Recirculation Adapter is indicated for recirculation of cardioplegia solution during cardiopulmonary bypass surgery, to keep the cardioplegia solution at constant temperature. The "Y" recirculation adapter consists of a flexible polyvinyl chloride tubing, "Y" connector, tubing clamps and connecting adapters in a "Y" configuration.
The Cardioplegia "Y" Perfusion Adapter is indicated for use in delivery of cardioplegia solution during cardiopulmonary bypass surgery. "The perfusion adapter consists of polyvinyl chloride tubing, tubing clamps, "Y" connector, and connecting adapters in a "Y" configuration.
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