The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Ritecath Intermittent Urinary Catheter.
Device ID | K142575 |
510k Number | K142575 |
Device Name: | Bard RiteCath Intermittent Urinary Catheter |
Classification | Catheter, Straight |
Applicant | C.R. Bard, Inc. 8195 Industrial Blvd Covington, GA 30014 |
Contact | Michele Davis |
Correspondent | Michele Davis C.R. Bard, Inc. 8195 Industrial Blvd Covington, GA 30014 |
Product Code | EZD |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-12 |
Decision Date | 2014-10-31 |
Summary: | summary |