Search Results
Found 3 results
510(k) Data Aggregation
K Number
K011783Device Name
MULTI-SNARE SET
Manufacturer
PFM PRODUKTE FUR DIE MEDIZIN AG
Date Cleared
2002-01-24
(231 days)
Product Code
DXE
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
PFM PRODUKTE FUR DIE MEDIZIN AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Multi-Snare Set (and its components) is intended for: Retrieval and manipulation of foreign objects from the vascular system and hollow viscera Assistance in creating loops where cross-over technique is applied Repositioning of indwelling venous catheters Assistance in performing venipuncture to obtain access to central vein
Device Description
The pfm Multi-Snare Set is contains of the following parts: - Inner wire which forms the loop; - Coil mounted on the inner wire in the loop section; - Shaft body consisting of an outside coil and a core wire; and - Transition from loop wire to shaft body. The Multi-Snare Set consists of a highly elastic Nitinol wire with a pre-formed loop on its distal end. The ware of the snare's highly elastic design, the snare can be introduced through an insertion sheath. The diameter of the snare can be adjusted depending on the position of the sheath. For better manipulation and torque-ability a torquer is provided. The introducer sheath is designed for interventional insertion of instruments and systems into the vascular system. The insertion sheath consists of polyethylene tubing, which is curved at its distal end and has a luer adapter at its proximal end. For better visualization the introducer sheath has an additional distal radiopaque marker.
Ask a Question
K Number
K002471Device Name
JETCAN HUBER NEEEDLE SET
Manufacturer
PFM PRODUKTE FUR DIE MEDIZIN AG
Date Cleared
2000-10-19
(69 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
PFM PRODUKTE FUR DIE MEDIZIN AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K001716Device Name
REDON SET
Manufacturer
PFM PRODUKTE FUR DIE MEDIZIN AG
Date Cleared
2000-07-19
(44 days)
Product Code
JCX
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
PFM PRODUKTE FUR DIE MEDIZIN AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1