The following data is part of a premarket notification filed by Usci, Div. C.r. Bard, Inc. with the FDA for Usci Dorros Infusion/probing Catheter.
Device ID | K884209 |
510k Number | K884209 |
Device Name: | USCI DORROS INFUSION/PROBING CATHETER |
Classification | Catheter, Percutaneous |
Applicant | USCI, DIV. C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica, MA 01821 |
Contact | Janice Piasecki |
Correspondent | Janice Piasecki USCI, DIV. C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica, MA 01821 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-06 |
Decision Date | 1988-12-21 |