The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed Diagnostic Ultrasound Catheter.
| Device ID | K063076 |
| 510k Number | K063076 |
| Device Name: | REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER |
| Classification | Reprocessed Intravascular Ultrasound Catheter |
| Applicant | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Jenn Selvey |
| Correspondent | Jenn Selvey ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | OWQ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-06 |
| Decision Date | 2007-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885825011376 | K063076 | 000 |
| 00885825011369 | K063076 | 000 |
| 00885825011352 | K063076 | 000 |
| 00885825011338 | K063076 | 000 |
| 00885825002350 | K063076 | 000 |
| 00885825002336 | K063076 | 000 |