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510(k) Data Aggregation
K Number
K063355Device Name
D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW
Manufacturer
NOVOSCI CORP.
Date Cleared
2007-07-27
(262 days)
Product Code
MPB
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
NOVOSCI CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dual Lumen Short Term Hemodialysis and Extra Flow (EF) Short Term Hemodialysis catheters are indicated for use in hemodialysis, hemoperfusion and apheresis for short-term duration of less than 30 days via the subclavian, femoral or jugular vein.
Device Description
The Joline D-Line Catheter ST family of catheters, consisting of the Dual Lumen Short Term Hemodialysis and Extra Flow (EF) Short Term Hemodialysis catheters are a polyurethane radiopaque catheter which allows for hemodialysis, hemoperfusion and apheresis. A crosssectional view of the shaft of the Joline D-Line Catheter ST catheters reveals a double "D" configuration -one "D" for the arterial lumen and the other for the venous lumen. In the Extra Flow (EF) Short Term design the venous lumen extends beyond the arterial lumen and terminates in a round tip. The Dual Lumen Short Term catheter has both lumens exiting together and incorporates side-holes along the shaft of the catheter body in its design. Two color-coded safety clamps, red and blue, identify arterial and venous extensions. lmportant information such as priming volume and catheter length is printed on both sides of the clamp. A swiveling suture ring is available to secure the catheter after placement. Two extensions merge into a tapered bifurcation joint or hub molded to the catheter body. These extensions can be straight, curved or curved-to-one-side. The finished kit consists of either the Dual Lumen Short Term Hemodialysis or Extra Flow ITIc Timenta Kit of Childers packaged with various accessory components. These components include: guidewire, introducer needle, dilator, and luer lock caps.
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K Number
K033270Device Name
NOVOSCI READY SYSTEM, MODEL RS-200
Manufacturer
NOVOSCI CORP.
Date Cleared
2004-02-13
(126 days)
Product Code
KFM
Regulation Number
870.4360Why did this record match?
Applicant Name (Manufacturer) :
NOVOSCI CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NovoSci ™ Ready System® is indicated for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.
Device Description
The NovoSci" Ready System® is a closed loop extracorporeal system providing circulatory, thermal and gas-exchange support for extracorporeal perfusion. The NovoSci" Ready System® is provided as a sterile system with a non-pyrogenic fluid pathway for single use only and is not to be re-sterilized by the user.
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K Number
K033328Device Name
NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT
Manufacturer
NOVOSCI CORP.
Date Cleared
2004-01-16
(92 days)
Product Code
DTL
Regulation Number
870.4290Why did this record match?
Applicant Name (Manufacturer) :
NOVOSCI CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NovoSci™ NovoCoat™ treated tubing and connectors are indicated for use in cardiopulmonary surgical procedures requiring extracorporeal support for periods up to 6 hours.
Device Description
The NovoSci ™ tubing and connectors treated with NovoCoat™ are sterile, single use only, disposable devices. They are used to connect cardiopulmonary bypass components used during surgery procedures requiring extracorporeal support. When used on devices for cardiopulmonary surgery, the NovoCoat™ treatment improves blood compatibility of non-biological surfaces in the extracorporeal circuit.
NovoSci™ tubing is polyvinyl chloride (PVC) tubing available in various sizes. The NovoSci™ connectors are polycarbonate in various configurations such as straight, reducing, "Y", with or without luer ports.
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