The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Crosser Recanalization System.
| Device ID | K112308 |
| 510k Number | K112308 |
| Device Name: | CROSSER RECANALIZATION SYSTEM |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | C.R. BARD, INC. 745 N. PASTORIA AVE Sunnyvale, CA 94085 |
| Contact | Timothy Wade |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-08-11 |
| Decision Date | 2011-08-17 |
| Summary: | summary |