The following data is part of a premarket notification filed by St. Jude Medical with the FDA for St Jude Medical, Is4 Flushing/funneling Tool.
Device ID | K113773 |
510k Number | K113773 |
Device Name: | ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL |
Classification | Catheter, Continuous Flush |
Applicant | ST. JUDE MEDICAL 15900 Valley View Court Sylmar, CA 91342 |
Contact | Geena George |
Correspondent | Geena George ST. JUDE MEDICAL 15900 Valley View Court Sylmar, CA 91342 |
Product Code | KRA |
CFR Regulation Number | 870.1210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-22 |
Decision Date | 2012-01-18 |
Summary: | summary |