The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Power Port-a-cath, Cath Ii, And P.a.s. Port T2 Power P.a.c. Implantable Venous Access Systems And Power Gripper Plus.
| Device ID | K072657 |
| 510k Number | K072657 |
| Device Name: | POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. Arden Hills, MN 55112 |
| Contact | Brian Haugstad |
| Correspondent | Brian Haugstad SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. Arden Hills, 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 | 2007-09-20 |
| Decision Date | 2007-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00610586032663 | K072657 | 000 |
| 10610586032769 | K072657 | 000 |
| 10610586032752 | K072657 | 000 |
| 10610586032745 | K072657 | 000 |
| 10610586032738 | K072657 | 000 |
| 10610586032721 | K072657 | 000 |
| 10610586032714 | K072657 | 000 |
| 10610586032707 | K072657 | 000 |
| 10610586032691 | K072657 | 000 |
| 10610586032684 | K072657 | 000 |
| 10610586032677 | K072657 | 000 |
| 10610586032653 | K072657 | 000 |
| 10610586032646 | K072657 | 000 |
| 10610586032639 | K072657 | 000 |
| 10610586032622 | K072657 | 000 |
| 10610586032615 | K072657 | 000 |
| 10610586031373 | K072657 | 000 |
| 10610586032776 | K072657 | 000 |
| 10610586032790 | K072657 | 000 |
| 10610586032806 | K072657 | 000 |
| 10610586040016 | K072657 | 000 |
| 10610586040009 | K072657 | 000 |
| 10610586039997 | K072657 | 000 |
| 10610586039980 | K072657 | 000 |
| 10610586039973 | K072657 | 000 |
| 10610586039966 | K072657 | 000 |
| 10610586032912 | K072657 | 000 |
| 10610586032905 | K072657 | 000 |
| 10610586032899 | K072657 | 000 |
| 10610586032882 | K072657 | 000 |
| 10610586032875 | K072657 | 000 |
| 10610586032868 | K072657 | 000 |
| 10610586032851 | K072657 | 000 |
| 10610586032837 | K072657 | 000 |
| 10610586032820 | K072657 | 000 |
| 10610586032813 | K072657 | 000 |
| 10610586030826 | K072657 | 000 |