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510(k) Data Aggregation
K Number
K062901Device Name
HEMOCATH II
Manufacturer
MED-CONDUIT, INC.
Date Cleared
2007-02-08
(134 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
MED-CONDUIT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HemoCath Hemodialysis/Apheresis Catheter is indicated for use in attaining long term vascular access for hemodialysis or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.
Device Description
The HemoCath II is radiopaque silicone, comprised of 2 single lumens used to remove and return blood through two segregated circular lumen passages. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed Dacron cuff allows for tissue ingrowth for long-term placement.
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K Number
K053123Device Name
PD CATH
Manufacturer
MED-CONDUIT, INC.
Date Cleared
2006-03-29
(142 days)
Product Code
FJS
Regulation Number
876.5630Why did this record match?
Applicant Name (Manufacturer) :
MED-CONDUIT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PD Cath is indicated for use in attaining long term peritoneal access for peritoneal dialysis via the peritoneum. The catheter is intended for implantation dwell time of greater than 30 days.
Device Description
The PD Cath is a radiopaque silicone, single lumen catheter used to insert and remove peritoneal fluid. The fixed Dacron cuff allows for tissue ingrowth for long-term placement. A flexible silicone overtube is permanently bonded to the lumen passages and the cuff to insulate the cuff from forces applied to the external or internal lumens.
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K Number
K043292Device Name
HEMOCATH
Manufacturer
MED-CONDUIT, INC.
Date Cleared
2005-03-16
(107 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
MED-CONDUIT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HemoCath Hemodialysis/Apheresis Catheter is indicated for use in attaining long term vascular access for hemodialysis or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.
Device Description
The HemoCath is a radiopaque silicone, double lumen catheter used to remove and return blood through two segregated circular lumen passages. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed Dacron cuff allows for tissue ingrowth for long-term placement.
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