The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System.
| Device ID | K130043 |
| 510k Number | K130043 |
| Device Name: | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Natalie Smith |
| Correspondent | Natalie Smith Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-08 |
| Decision Date | 2013-02-12 |
| Summary: | summary |