K082725 is an FDA 510(k) clearance for the GRAFTGUARD PRESSURE CONTROLLING SYRINGE. This device is classified as a Catheter, Irrigation (Class I - General Controls, product code GBX).
Submitted by Maquet Cardiovascular, LLC (San Jose, US). The FDA issued a Cleared decision on December 17, 2008, 91 days after receiving the submission on September 17, 2008.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K082725 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2008 |
| Decision Date | December 17, 2008 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GBX — Catheter, Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |