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510(k) Data Aggregation
K Number
K955110Device Name
NAVARRE PERCUTANEOUS BILIARY DRAINAGE
Manufacturer
Date Cleared
1996-11-07
(365 days)
Product Code
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
NAVARRE BIOMEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the Percutaneous Biliary Drainage Intended Use: Catheter is to treat patients with obstructive jaundice, sepsis, and hepatic decompensation and pre-operative decompression.
Device Description
The proposed Percutaneous Biliary Drainage Catheter is identical to the predicate Navarre Locking Pigtail Universal Drainage Catheter in that they have identical tip-locking mechanisms. They differ only in the length of the distal ported section, catheter length, addition of a flexible cannula, number of drain holes, and the addition of a biliary septum to inject fluids into the bile duct.
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K Number
K955505Device Name
OPTI-DRAIN MULTI-USE DRAINAGE CATHETER
Manufacturer
Date Cleared
1996-02-07
(68 days)
Product Code
Regulation Number
878.4200Why did this record match?
Applicant Name (Manufacturer) :
NAVARRE BIOMEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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