Search Results
Found 7 results
510(k) Data Aggregation
K Number
K003753Device Name
GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE
Manufacturer
URESIL CORP.
Date Cleared
2001-01-04
(30 days)
Product Code
FGE, GBO, GBX, LJE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
URESIL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K980278Device Name
URESIL VASCU-FLO INFUSION CATHETER
Manufacturer
URESIL CORP.
Date Cleared
1998-11-20
(298 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
URESIL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to infuse therapeutic agents into the extra-cardiac vasculature.
Device Description
Not Found
Ask a Question
K Number
K981344Device Name
URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING
Manufacturer
URESIL CORP.
Date Cleared
1998-09-10
(154 days)
Product Code
LJE, FGE, GBO, GBX
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
URESIL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For percutaneous drainage of abscess, nephrostomy and other fluids.
Device Description
Not Found
Ask a Question
K Number
K980282Device Name
URESIL DILATOR WITH RADIOPAQUE MARKER
Manufacturer
URESIL CORP.
Date Cleared
1998-04-24
(88 days)
Product Code
DRE
Regulation Number
870.1310Why did this record match?
Applicant Name (Manufacturer) :
URESIL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to help create a tract for catheter insertion.
Device Description
Not Found
Ask a Question
K Number
K980889Device Name
URESIL NEPHRO-URETERAL STENT
Manufacturer
URESIL CORP.
Date Cleared
1998-04-08
(30 days)
Product Code
LJE
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
URESIL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This catheter/stent is intended for use when the physician selects a patient suitable for percutaneous drainage from the ureterpelvic junction to the bladder while maintaining external access.
Device Description
Modified Uresil® Nephro-Ureteral Stent
Ask a Question
K Number
K972582Device Name
URESIL GUIDEWIRE
Manufacturer
URESIL CORP.
Date Cleared
1997-11-21
(134 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
URESIL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for use in percutaneous nephrostomy, biliary und abscess drainage and other gastrointestinal and genitourinary procedures.
Device Description
Not Found
Ask a Question
K Number
K972583Device Name
URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S
Manufacturer
URESIL CORP.
Date Cleared
1997-08-29
(50 days)
Product Code
FGE, GBO, GBX
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
URESIL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For percutaneous drainage of abscess, nephrostomy and other fluids.
Device Description
Uresil General Purpose Drainage Catheters
Ask a Question
Page 1 of 1