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510(k) Data Aggregation
K Number
K973485Device Name
CLEARVIEW BLOWER/MISTER
Manufacturer
DLP, INC.
Date Cleared
1997-12-08
(84 days)
Product Code
FQH
Regulation Number
880.5475Why did this record match?
Applicant Name (Manufacturer) :
DLP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for use during procedures when a wound or surgical site must be cleared by non-contact means for improved visibility at the site.
Device Description
The ClearView Blower/Mister includes a hand grip with a 3 1/4" or 6 1/2" malleable stainless steel shaft for ease of positioning the device near the surgical site. The soft, silicone tip contains a plastic tube which carries saline to the tip. The proximal end includes a fluid inlet line which terminates in a locking female luer for connection to the fluid administration set. The gas line, located on the proximal end, has an in-line 0.2 micron filter and terminates in a slip connector for connection to the gas source tubing.
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K Number
K964445Device Name
OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)
Manufacturer
DLP, INC.
Date Cleared
1997-01-30
(85 days)
Product Code
DWS
Regulation Number
870.4500Why did this record match?
Applicant Name (Manufacturer) :
DLP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications or intended use for the DLP Octopus™ Tissue Stabilizer and the predicate product, Cardiothoracic Systems, Inc. (CTS) Thoracic Access Platform and Stabilizer are the same. Both are intended for use du ring coronary artery bypass grafting to isolate diseased artery and minimize motion of the beating heart to facilitate the grafting procedure.
Device Description
The design of the Octopus"" is similar to both predicate products referenced in the Comparison Information Section. It features plastic handle with vacuum tubing connection, malleable stainless steel arm and suction tip similar to the DLP Cardiac Suction Tube product. The "feet" design of the Octopus" is intended to position the anastomosis site between two "feet" for isolation and stabilization control which is the same as the CTS Thoracic Access Platform and Stabilizer.
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K Number
K953945Device Name
RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET
Manufacturer
DLP, INC.
Date Cleared
1996-03-26
(218 days)
Product Code
DWF
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
DLP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications or intended use for the DLP Elongated and Treaded Cuff Retrograde Coronary Sinus Perfusion (RCSP) cannula are the same as the DLP, Research Medical and Sarns 3M marketed RCSP cannula. The cannula are intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus.
Device Description
The design of the DLP Elongated and Treaded Cuff RCSP cannula is similar to predicate products. Size and shape contain minor differences. Technological characteristics are equivalent. Cuff length and texture differences do not affect flow characteristics.
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