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 |