The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Irrigation Catheter 4, 6 And 10 French.
Device ID | K902256 |
510k Number | K902256 |
Device Name: | IRRIGATION CATHETER 4, 6 AND 10 FRENCH |
Classification | Catheter, Percutaneous |
Applicant | APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
Contact | Robert P Cooper |
Correspondent | Robert P Cooper APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-21 |
Decision Date | 1991-02-15 |