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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K030715
Device Name SAFFRON NM GUIDING CATHETER
Applicant
Neich Medical (Shenzhen) Company Limited
#1 Jinkui Rd.
Futian Free Trade Zone
Shenzhen,  CN 518038
Applicant Contact RAYMOND LIN
Correspondent
Neich Medical (Shenzhen) Company Limited
#1 Jinkui Rd.
Futian Free Trade Zone
Shenzhen,  CN 518038
Correspondent Contact RAYMOND LIN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/07/2003
Decision Date 04/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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