The following data is part of a premarket notification filed by Curative Medical Technology, Inc. with the FDA for Ursa Angiographic Catheter.
| Device ID | K123818 |
| 510k Number | K123818 |
| Device Name: | URSA ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | CURATIVE MEDICAL TECHNOLOGY, INC. 6518 TAMARIND SKY LANE Fulshear, TX 77441 |
| Contact | Amy Mckinney |
| Correspondent | Amy Mckinney CURATIVE MEDICAL TECHNOLOGY, INC. 6518 TAMARIND SKY LANE Fulshear, TX 77441 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-12 |
| Decision Date | 2013-03-04 |
| Summary: | summary |