The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Cardiotomy Reservoir W/20 Micron Filiter.
| Device ID | K920178 |
| 510k Number | K920178 |
| Device Name: | CARDIOTOMY RESERVOIR W/20 MICRON FILITER |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands, TX 77381 |
| Contact | Russell Jones |
| Correspondent | Russell Jones LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands, TX 77381 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-14 |
| Decision Date | 1993-05-13 |