The following data is part of a premarket notification filed by Novalung Gmbh with the FDA for Novaport One Vascular Access Cannula.
| Device ID | K112565 |
| 510k Number | K112565 |
| Device Name: | NOVAPORT ONE VASCULAR ACCESS CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | NOVALUNG GMBH 3550 WEST LIBERTY RD. Ann Arbor, MI 48103 |
| Contact | Leann Christman |
| Correspondent | Leann Christman NOVALUNG GMBH 3550 WEST LIBERTY RD. Ann Arbor, MI 48103 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-02 |
| Decision Date | 2011-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260058550759 | K112565 | 000 |
| 04260058550742 | K112565 | 000 |
| 04260058550735 | K112565 | 000 |
| 04260058550728 | K112565 | 000 |