The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Usci Balloon Dilatation Inflation Dev..
Device ID | K791782 |
510k Number | K791782 |
Device Name: | USCI BALLOON DILATATION INFLATION DEV. |
Classification | Injector And Syringe, Angiographic |
Applicant | C.R. BARD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXT |
CFR Regulation Number | 870.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-09-12 |
Decision Date | 1979-12-11 |