The following data is part of a premarket notification filed by Cruzar Medsystems Inc with the FDA for Houdini Cross Support Catheter.
| Device ID | K213466 |
| 510k Number | K213466 |
| Device Name: | Houdini Cross Support Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Cruzar Medsystems Inc 50 Braintree Hill Office Park Suite 301 Braintree, MA 02184 |
| Contact | Dave Tornatore |
| Correspondent | Adrienne Von Foller Strategic Quality Solutions LLC 1594 E Monaco Ave Salt Lake City, UT 84121 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-28 |
| Decision Date | 2022-10-20 |