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510(k) Data Aggregation
K Number
K140085Device Name
UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
Manufacturer
COOK INCORPORATED
Date Cleared
2014-11-18
(309 days)
Product Code
FEW, KOB, LJE
Regulation Number
876.5090Why did this record match?
Product Code :
FEW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Universa® Loop Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.
The Universa® Malecot Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.
Device Description
The Universa® Percutaneous Drainage Catheter Sets include introductory and exchange sets available with either a loop (6-14 Fr) or a Malecot catheter (8-24 Fr). Suprapubic sets are available with a Malecot catheter (8-16 Fr). Each set includes a drainage catheter and connecting tube, and may also include straightening stylets, trocar needle with obturator, hollow needle, wire guide, dilators, silicone retention disc with pull tie, or one-way stopcock. The devices will be supplied sterile and intended for one-time use.
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K Number
K070879Device Name
BARD MALECOT AND PEZZER DRAINS
Manufacturer
C.R. BARD, INC.
Date Cleared
2007-04-24
(25 days)
Product Code
FEW
Regulation Number
876.5090Why did this record match?
Product Code :
FEW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bard malecot and pezzer drains are intended for use in the drainage of urine. The drains are inserted suprapubically into the bladder or through a nephrostomy tract.
Device Description
The drains are composed of a straight or angled, single lumen catheter shaft. The proximal end, which remains external to the patient, is a funnel for connection to a urine collection device. The funnel is printed with a product code, date code, product type and French size, The distal end, which is placed in the patient, is offered in various configurations including whistle tip, 2-wing, 4-wing, retention head with drainage eyes or open end retention head. The entire drain is composed of natural rubber latex.
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K Number
K981258Device Name
MANAN MALECOT BASKET DRAINAGE CATHETER
Manufacturer
MEDICAL DEVICE TECHNOLOGIES, INC.
Date Cleared
1998-04-22
(16 days)
Product Code
FEW
Regulation Number
876.5090Why did this record match?
Product Code :
FEW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Manan™ Malecot Basket Drainage Catheter is for percutaneous nephrostomy and abcess drainage.
Device Description
Manan drainage catheters are made from a biocompatible urethane (Tecoflex) that has been used extensively in both short and long term implantable medical devices. This material softens at body temperature thus minimizing tissue trauma. The catheters come in malecot end configuration. Also included with the catheters are flexible stiffening cannula.
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K Number
K954147Device Name
MANAN MALECOT BASKET DRAINAGE CATHETER
Manufacturer
MANAN MEDICAL PRODUCTS, INC.
Date Cleared
1996-03-26
(203 days)
Product Code
FEW
Regulation Number
876.5090Why did this record match?
Product Code :
FEW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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