The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Crosser Iq Cto Recanalization System.
| Device ID | K203363 |
| 510k Number | K203363 |
| Device Name: | Crosser IQ CTO Recanalization System |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | C.R. Bard, Inc. 1625 West 3rd St Tempe, AZ 85281 |
| Contact | Aaron Conovaloff |
| Correspondent | Aaron Conovaloff C.R. Bard, Inc. 1625 West 3rd St Tempe, AZ 85281 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-16 |
| Decision Date | 2021-08-12 |