The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Conquest Pta Balloon Dilatation Catheter.
Device ID | K083657 |
510k Number | K083657 |
Device Name: | CONQUEST PTA BALLOON DILATATION CATHETER |
Classification | Catheter, Percutaneous |
Applicant | C.R. BARD, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 -1740 |
Contact | Genevieve Balutowski |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2008-12-10 |
Decision Date | 2008-12-24 |
Summary: | summary |