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510(k) Data Aggregation
K Number
K081713Device Name
VERTEBRAL ACCESS SYSTEM BY VIDACARE
Manufacturer
VIDACARE CORPORATION
Date Cleared
2008-11-21
(157 days)
Product Code
MOQ, OAR
Regulation Number
878.4820Why did this record match?
Product Code :
MOQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vertebral Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty. This system does not contain cement.
Device Description
The Vertebral Access System by Vidacare® consists of a reusable Power Driver and a disposable sterile needle set in a sealed tray. The sealed tray contains 1 coupler with driver sterile sleeve, 1 beveled needle set and 2 sharps protectors. The Vertebral Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The 11 gauge, 152mm needle set is identical in gauge and length to the predicate devices: OnControl™ Bone Marrow Biopsy System (cleared via K072045) and the Parallax EZFlow Cement Delivery System (cleared via K051820). The powered driver is identical to the predicate driver cleared via K072045.
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K Number
K013133Device Name
NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
Manufacturer
NORDIX, INC.
Date Cleared
2001-11-13
(55 days)
Product Code
MOQ, MOZ
Regulation Number
878.4820Why did this record match?
Product Code :
MOQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Replacement Battery for Baxter Flo-Gard Pump 8000, 8100, 8200 Infusion Pumps inidator. Formps This battery is sold only to customers who request a replacement battery for a particular device or to replace a competitor's Dattery for a particular dovice of to a loss equipment technician knows the intended use is as a replacement battery.
Device Description
Nordix Rechargeable Battery Part Number 2116
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K Number
K980224Device Name
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822
Manufacturer
ALEXANDER MFG. CO.
Date Cleared
1998-04-02
(70 days)
Product Code
MOQ
Regulation Number
878.4820Why did this record match?
Product Code :
MOQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Replacement battery for IVAC Corp. 124915 Electronic Clinical Thermometer 2000, 510(k) Number K820409.
This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
Device Description
Rechargeable Battery Part Number MS822
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