The following data is part of a premarket notification filed by Peripheral Systems Group with the FDA for Psg Hemostatic Control Valve.
Device ID | K904959 |
510k Number | K904959 |
Device Name: | PSG HEMOSTATIC CONTROL VALVE |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
Contact | Linda Guthrie |
Correspondent | Linda Guthrie PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-05 |
Decision Date | 1990-12-17 |