The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Tmp Left Atrial Pressure Cath Cat.# 100-00x-000.
| Device ID | K904491 |
| 510k Number | K904491 |
| Device Name: | TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands, TX 77381 |
| Contact | Thomas Wertz |
| Correspondent | Thomas Wertz LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands, TX 77381 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-02 |
| Decision Date | 1991-02-01 |