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510(k) Data Aggregation
K Number
K981809Device Name
CAROLINE GUIDE
Manufacturer
Date Cleared
1998-08-14
(85 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Caroline Guide is intended for use by neurosurgeons during posterior ventricular catheter placement procedures.
Statement of indications for use:
The Caroline Guide is indicated for use by neurosurgeons for posterior ventricular catheter placement for patients who are:
1) Adults or children
2) Have enlarged ventricles
3) Have no intracranial mass legions or any structural abnormalities other than hydrocephalus
4) Have no general contraindications to surgery
Device Description
The Caroline Guide is a mechanical device that helps the surgeon orient a ventricular catheter along a straight line connecting the posterior burr hole entrance point and a frontal target point.
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K Number
K973277Device Name
CAROLINE GUIDE/DELIA LOCALIZER
Manufacturer
Date Cleared
1997-11-17
(76 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Delia Localizer and Caroline Guide are indicated for use by neurosurgeons as shunt accessories for patients scheduled to undergo a posterior ventricular catheter placement procedure who are: 1) Adults 2) Have enlarged ventricles 3) Have normal scalp, skull, external ear and orbital anatomy 4) Do not have intracranial mass lesions or any structural abnormalities other than hydrocephalus 5) Have no general contraindications to surgery
Device Description
The Delia Localizer is a head-band based apparatus that aids the surgeon in identifying the optimal location for placing a posterior burr hole for purposes of inserting a posterior ventricular catheter. It mechanically reduces to practice geometric principles that are already used to manually calculate where to position a posterior burr hole. The Caroline Guide is a mechanical device that helps the surgeon orient a ventricular catheter along a straight line connecting the posterior burr hole entrance point and the frontal target point.
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