The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Copilot Bleedback Control Valve, Model 1003331.
| Device ID | K991102 |
| 510k Number | K991102 |
| Device Name: | COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | GUIDANT CORP. 26531 YNEZ RD. Temecula, CA 92591 -4630 |
| Contact | Stacey Simon |
| Correspondent | Stacey Simon GUIDANT CORP. 26531 YNEZ RD. Temecula, CA 92591 -4630 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-01 |
| Decision Date | 1999-06-09 |
| Summary: | summary |