The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Angel Whole Blood Separation System.
| Device ID | K042473 |
| 510k Number | K042473 |
| Device Name: | COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 -3599 |
| Contact | Jack Ellison |
| Correspondent | Jack Ellison COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 -3599 |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-13 |
| Decision Date | 2004-11-19 |
| Summary: | summary |