The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Stone Removal Balloon Catheter.
| Device ID | K920342 |
| 510k Number | K920342 |
| Device Name: | BARD STONE REMOVAL BALLOON CATHETER |
| Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Applicant | C.R. BARD, INC. ONE PARK WEST Tewksbury, MA 01876 -1234 |
| Contact | Jeanette Schier |
| Correspondent | Jeanette Schier C.R. BARD, INC. ONE PARK WEST Tewksbury, MA 01876 -1234 |
| Product Code | GCA |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-27 |
| Decision Date | 1992-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405053801 | K920342 | 000 |
| 20653405053795 | K920342 | 000 |
| 20653405053788 | K920342 | 000 |
| 20653405053771 | K920342 | 000 |
| 20653405053764 | K920342 | 000 |