The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Soundstar 3d Diagnostic Ultrasound Catheter.
| Device ID | K170474 |
| 510k Number | K170474 |
| Device Name: | Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter |
| Classification | Reprocessed Intravascular Ultrasound Catheter |
| Applicant | Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Contact | Amy Stoklas-oakes |
| Correspondent | Amy Stoklas-oakes Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Product Code | OWQ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-16 |
| Decision Date | 2017-06-16 |
| Summary: | summary |