The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Power Port-a-cath And Power Port-a-cath Ii; Implantable Venous Access Systems And Power Gripper Plus Needle.
| Device ID | K070116 |
| 510k Number | K070116 |
| Device Name: | POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Phil Neururer |
| Correspondent | Phil Neururer SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. 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 | 2007-01-12 |
| Decision Date | 2007-05-23 |
| Summary: | summary |