The following data is part of a premarket notification filed by Mckinley, Inc. with the FDA for Mckinley Outbound-2 System.
| Device ID | K971844 |
| 510k Number | K971844 |
| Device Name: | MCKINLEY OUTBOUND-2 SYSTEM |
| Classification | Set, Administration, Intravascular |
| Applicant | MCKINLEY, INC. 4080 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Contact | Brian D Zdeb |
| Correspondent | Brian D Zdeb MCKINLEY, INC. 4080 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-19 |
| Decision Date | 1998-01-23 |