The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Tigertail Ureteral Catheter.
Device ID | K033719 |
510k Number | K033719 |
Device Name: | BARD TIGERTAIL URETERAL CATHETER |
Classification | Catheter, Urological |
Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
Contact | Frances Harrison |
Correspondent | Frances Harrison C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
Product Code | KOD |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-11-26 |
Decision Date | 2004-02-04 |
Summary: | summary |