The following data is part of a premarket notification filed by C. R. Bard, Inc. with the FDA for Bard Vertus Foley Catheter.
Device ID | K180781 |
510k Number | K180781 |
Device Name: | Bard Vertus Foley Catheter |
Classification | Catheter, Retention Type, Balloon |
Applicant | C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014 |
Contact | Sharon Lambert |
Correspondent | Sharon Lambert C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014 |
Product Code | EZL |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-03-26 |
Decision Date | 2018-09-19 |
Summary: | summary |