The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed 3d Diagnostic Ultrasound Catheters, Model Sndstr10.
| Device ID | K092425 |
| 510k Number | K092425 |
| Device Name: | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 |
| Classification | Reprocessed Intravascular Ultrasound Catheter |
| Applicant | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Amanda Babcock |
| Correspondent | Amanda Babcock 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 | 2009-08-07 |
| Decision Date | 2009-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885825020958 | K092425 | 000 |
| 00885825020941 | K092425 | 000 |
| 00885825020927 | K092425 | 000 |
| 00885825020910 | K092425 | 000 |
| 00885825002343 | K092425 | 000 |
| 00885825002329 | K092425 | 000 |