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510(k) Data Aggregation
K Number
K100135Device Name
GDS-DC12
Manufacturer
Date Cleared
2010-04-16
(87 days)
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
GUIDED DELIVERY SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GDS-DC12 is intended to facilitate the intracardiac placement of interventional devices such as guidewires.
Device Description
GDS-DC12 is a polymeric, single use, sterile, non-pyrogenic, disposable intracardiac catheter of various sizes and curvatures with a deflectable tip and hemostasis valve.
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K Number
K091367Device Name
GDS-DCS
Manufacturer
Date Cleared
2009-11-05
(181 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
GUIDED DELIVERY SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GDS-DC6 is intended to facilitate the intracardiac placement of interventional devices such as guidewires.
Device Description
GDS-DC6 is a polymeric, single use, sterile, non-pyrogenic, disposable intracardiac catheter of various sizes and curvatures.
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