The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Sentry Smarxt 43 Micron Arterial Filter With Primegard.
| Device ID | K982254 |
| 510k Number | K982254 |
| Device Name: | COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Contact | Lynne Leonard |
| Correspondent | Lynne Leonard COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-26 |
| Decision Date | 1998-09-10 |
| Summary: | summary |