The following data is part of a premarket notification filed by Waters Assoc., Inc. with the FDA for 7french Flow Directed Triple Lumen Cath.
Device ID | K802481 |
510k Number | K802481 |
Device Name: | 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH |
Classification | Catheter, Flow Directed |
Applicant | WATERS ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DYG |
CFR Regulation Number | 870.1240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-07 |
Decision Date | 1980-10-31 |