The following data is part of a premarket notification filed by Fresenius Hemotechnology, Inc. with the FDA for Fresenius C.a.t.s; Ati Autotransfusion Set; Psq Plasma Sequestration Set; Psq-dd Plasma Sequestration Direct Draw.
| Device ID | K012178 |
| 510k Number | K012178 |
| Device Name: | FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW |
| Classification | Apparatus, Autotransfusion |
| Applicant | FRESENIUS HEMOTECHNOLOGY, INC. 6675 185TH AVE. NE, SUITE 100 Redmond, WA 98052 |
| Contact | Tom Trotter |
| Correspondent | Tom Trotter FRESENIUS HEMOTECHNOLOGY, INC. 6675 185TH AVE. NE, SUITE 100 Redmond, WA 98052 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-12 |
| Decision Date | 2001-07-23 |
| Summary: | summary |