The following data is part of a premarket notification filed by Curative Medical Technology, Inc. with the FDA for Ursa Angiographic Catheter.
| Device ID | K090427 |
| 510k Number | K090427 |
| Device Name: | URSA ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | CURATIVE MEDICAL TECHNOLOGY, INC. 102 MISTLETOE ST. Lake Jackson, TX 77566 |
| Contact | Amy Mckinney |
| Correspondent | Amy Mckinney CURATIVE MEDICAL TECHNOLOGY, INC. 102 MISTLETOE ST. Lake Jackson, TX 77566 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-19 |
| Decision Date | 2010-01-29 |
| Summary: | summary |