The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Rapido Cut-away Bleedback Control Valve (bbcv), Model 7568.
| Device ID | K031903 |
| 510k Number | K031903 |
| Device Name: | RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | GUIDANT CORPORATION 4100 HAMLINE AVE NORTH St Paul, MN 55112 -5798 |
| Contact | Stephanie I Robinson |
| Correspondent | Stephanie I Robinson GUIDANT CORPORATION 4100 HAMLINE AVE NORTH St Paul, MN 55112 -5798 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-20 |
| Decision Date | 2004-03-03 |
| Summary: | summary |