The following data is part of a premarket notification filed by Innovative Health, Llc with the FDA for Reprocessed Diagnostic Ultrasound Catheter.
| Device ID | K153090 |
| 510k Number | K153090 |
| Device Name: | Reprocessed Diagnostic Ultrasound Catheter |
| Classification | Reprocessed Intravascular Ultrasound Catheter |
| Applicant | INNOVATIVE HEALTH, LLC 1435 NORTH HAYDEN ROAD, SUITE 100 Scottsdale, AZ 85257 |
| Contact | Rafal Chudzik |
| Correspondent | Rafal Chudzik 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 | 2015-10-26 |
| Decision Date | 2016-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841898110122 | K153090 | 000 |
| 10841898110092 | K153090 | 000 |