The following data is part of a premarket notification filed by Levitronix Llc with the FDA for Centrimag Drainage Cannula Kit.
| Device ID | K110983 |
| 510k Number | K110983 |
| Device Name: | CENTRIMAG DRAINAGE CANNULA KIT |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | LEVITRONIX LLC 45 FIRST AVE. Waltham, MA 02451 |
| Contact | Lydia Sakakeeny |
| Correspondent | Lydia Sakakeeny LEVITRONIX LLC 45 FIRST AVE. Waltham, MA 02451 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-07 |
| Decision Date | 2011-06-20 |
| Summary: | summary |