The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Intimax(tm) Irrigation Catheter.
Device ID | K911181 |
510k Number | K911181 |
Device Name: | INTIMAX(TM) IRRIGATION CATHETER |
Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
Applicant | APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
Contact | Jo Stegwell |
Correspondent | Jo Stegwell APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
Product Code | GCA |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-18 |
Decision Date | 1991-04-18 |