The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Pleur-evac Sahara Plus Continuous Reinfusion And Autotransfusion System.
| Device ID | K140205 |
| 510k Number | K140205 |
| Device Name: | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | Teleflex Medical, Inc. 2917 WECK DR. PO BOX 12600 Research Triangle Park, NC 27709 |
| Contact | Holly Kornegay |
| Correspondent | Holly Kornegay Teleflex Medical, Inc. 2917 WECK DR. PO BOX 12600 Research Triangle Park, NC 27709 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-27 |
| Decision Date | 2014-10-23 |
| Summary: | summary |