The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Ritecath Intermittent Catheter.
Device ID | K133470 |
510k Number | K133470 |
Device Name: | BARD RITECATH INTERMITTENT 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 | 2013-11-12 |
Decision Date | 2014-04-04 |
Summary: | summary |