The following data is part of a premarket notification filed by Perouse Medical with the FDA for Polysite Implantable Infusion Ports.
| Device ID | K122834 |
| 510k Number | K122834 |
| Device Name: | POLYSITE IMPLANTABLE INFUSION PORTS |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | Perouse Medical Route Du Manoir Ivry-le-Temple France, FR 60173 |
| Contact | Isabelle Jeanty |
| Correspondent | Isabelle Jeanty Perouse Medical Route Du Manoir Ivry-le-Temple France, FR 60173 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-17 |
| Decision Date | 2013-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 13661234011633 | K122834 | 000 |
| 13661234017611 | K122834 | 000 |
| 13661234017604 | K122834 | 000 |
| 13661234017598 | K122834 | 000 |
| 13661234017581 | K122834 | 000 |
| 13661234017574 | K122834 | 000 |
| 13661234017567 | K122834 | 000 |
| 13661234017550 | K122834 | 000 |
| 13661234017543 | K122834 | 000 |
| 20801902189572 | K122834 | 000 |
| 20801902189565 | K122834 | 000 |
| 20801902189558 | K122834 | 000 |
| 20801902189541 | K122834 | 000 |
| 20801902189527 | K122834 | 000 |
| 13661234017628 | K122834 | 000 |
| 13661234017635 | K122834 | 000 |
| 13661234011626 | K122834 | 000 |
| 13661234011619 | K122834 | 000 |
| 13661234011602 | K122834 | 000 |
| 13661234011596 | K122834 | 000 |
| 13661234011589 | K122834 | 000 |
| 13661234011572 | K122834 | 000 |
| 13661234011565 | K122834 | 000 |
| 13661234011558 | K122834 | 000 |
| 13661234011541 | K122834 | 000 |
| 13661234011534 | K122834 | 000 |
| 13661234011527 | K122834 | 000 |
| 13661234017659 | K122834 | 000 |
| 03661234017645 | K122834 | 000 |
| 20801902189619 | K122834 | 000 |