The following data is part of a premarket notification filed by Intramed Laboratories, Inc. with the FDA for Clearview(tm) Angioscopic Irrigation Pump.
| Device ID | K902444 |
| 510k Number | K902444 |
| Device Name: | CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP |
| Classification | Withdrawal/infusion Pump |
| Applicant | INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Contact | A Sosnowski |
| Correspondent | A Sosnowski INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Product Code | DQI |
| CFR Regulation Number | 870.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-01 |
| Decision Date | 1990-08-30 |