Search Results
Found 2 results
510(k) Data Aggregation
K Number
K990765Device Name
FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO
Manufacturer
FLEXMEDICS
Date Cleared
1999-03-15
(7 days)
Product Code
OCY
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
FLEXMEDICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FlexFinder® ENCAP guidewire is designed to be used to guide and exchange endoscopic accessories and clinical capabilities for biliary procedures. The FlexFinder® guidewire is indicated for selective cannulation of the biliary ducts, including, cystic, pancreatic, and right and left hepatic ducts.
Device Description
Not Found
Ask a Question
K Number
K964955Device Name
FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING
Manufacturer
FLEXMEDICS
Date Cleared
1997-02-14
(65 days)
Product Code
OCY
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
FLEXMEDICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FlexFinder® Guidewire is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The FlexFinder® Guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile, cystic, pancreatic, and right and left hepatic ducts.
Device Description
The FlexFinder® Guidewire is available in a nominal diameter of 0.035" with marked and unmarked models encompassing lengths between 260 - 450 cm. The guidewire is constructed of a Nitinol, kink resistant core wire encapsulated in a PTFE coating. The core wire is tapered to provide flexibility of the distal tip. The guidewire is provided in two shaft flexibility's; regular shaft and stiff shaft. The guidewire will be available in both ink marked and unmarked models of each of the shaft flexibility's. For the marked models, the distal portion of the guidewire is marked visually with ink bands to allow for endoscopic detection of wire movement during a clinical procedure. The encapsulated guidewire enables it to be used with wire guided electrosurgical devices providing insulation from the electrosurgical current during a procedure. The insulation meets the AAMI standard for High frequency Therapeutic devices(HF 18) which describes testing for reliability, safety, and effectiveness. The guidewires are packaged, sterilized, and labeled and intended for one procedure use only(disposable).
Ask a Question
Page 1 of 1