The following data is part of a premarket notification filed by Cruzar Medsystems, Inc. with the FDA for Houdini Catheter.
| Device ID | K151896 |
| 510k Number | K151896 |
| Device Name: | Houdini Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Cruzar Medsystems, Inc. 50 Braintree Hill Office Park, Suite 301 Braintree, MA 02184 |
| Contact | Tom Kramer |
| Correspondent | Gina To Cruzar Medsystems, Inc. 50 Braintree Hill Office Park, Suite 301 Braintree, MA 02184 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-10 |
| Decision Date | 2015-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860554000396 | K151896 | 000 |
| 00860554000365 | K151896 | 000 |
| 00860554000358 | K151896 | 000 |
| 00860554000334 | K151896 | 000 |
| 00860554000327 | K151896 | 000 |