The following data is part of a premarket notification filed by Maquet Cardiovascular, Llc with the FDA for Graftguard Pressure Controlling Syringe.
| Device ID | K082725 |
| 510k Number | K082725 |
| Device Name: | GRAFTGUARD PRESSURE CONTROLLING SYRINGE |
| Classification | Catheter, Irrigation |
| Applicant | MAQUET CARDIOVASCULAR, LLC 170 BAYTECH DRIVE San Jose, CA 95134 |
| Contact | Christina L Rowe |
| Correspondent | Christina L Rowe MAQUET CARDIOVASCULAR, LLC 170 BAYTECH DRIVE San Jose, CA 95134 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-17 |
| Decision Date | 2008-12-17 |
| Summary: | summary |