The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Port-a-cath Power P.a.c. Implantable Venous Access Systems.
| Device ID | K093414 |
| 510k Number | K093414 |
| Device Name: | PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | SMITHS MEDICAL ASD, INC. 1265 GREY FOX ROAD St. Paul, MN 55112 |
| Contact | Rachelle Parsons |
| Correspondent | Rachelle Parsons SMITHS MEDICAL ASD, INC. 1265 GREY FOX ROAD St. Paul, MN 55112 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-02 |
| Decision Date | 2010-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610586032660 | K093414 | 000 |