The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed Guidant Cardiac Stabilization And Positioning Devices.
| Device ID | K070034 |
| 510k Number | K070034 |
| Device Name: | REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES |
| Classification | Stabilizer, Heart, Non-compression, Reprocessed |
| Applicant | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Katie Bray |
| Correspondent | Katie Bray ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | NQG |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-03 |
| Decision Date | 2007-08-17 |
| Summary: | summary |