The following data is part of a premarket notification filed by Fresenius Hemotechnology, Inc. with the FDA for C.a.t.s Autotransfusion Accessories, Models Ats Suction Line, Aty Y-adapter, And Ato Oxygenator Line.
| Device ID | K984233 |
| 510k Number | K984233 |
| Device Name: | C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE |
| Classification | Apparatus, Autotransfusion |
| Applicant | FRESENIUS HEMOTECHNOLOGY, INC. 110 MASON CIRCLE SUITE A Concord, CA 94520 -1238 |
| Contact | Virginia R Singer |
| Correspondent | Virginia R Singer FRESENIUS HEMOTECHNOLOGY, INC. 110 MASON CIRCLE SUITE A Concord, CA 94520 -1238 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-25 |
| Decision Date | 1999-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04052682000669 | K984233 | 000 |
| 04052682000645 | K984233 | 000 |
| 04052682000577 | K984233 | 000 |