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510(k) Data Aggregation
K Number
K032888Device Name
CREATION NM DIAGNOSTIC CATHETERS
Manufacturer
NEICH MEDICAL (SHENZHEN) COMPANY LIMITED
Date Cleared
2004-02-24
(161 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
NEICH MEDICAL (SHENZHEN) COMPANY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Neich Modical Creation NM™ Diagnostic Catheters are designed to deliver radiopaque contrast thediturn to selected sites in the vascular system,
Device Description
Creation NM™ Diagnostic Catheter
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K Number
K030715Device Name
SAFFRON NM GUIDING CATHETER
Manufacturer
NEICH MEDICAL (SHENZHEN) COMPANY LIMITED
Date Cleared
2003-04-24
(48 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
NEICH MEDICAL (SHENZHEN) COMPANY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Saffron NM™ Guiding Catheter is indicated for use for intravascular introduction of interventional/diagnostic devices into coronary or peripheral vascular systems.
Device Description
Not Found
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