GRAFTGUARD PRESSURE CONTROLLING SYRINGE— 510(k) K082725
Substantially EquivalentMaquet Cardiovascular, LLC
FDA 510(k) clearance K082725 for GRAFTGUARD PRESSURE CONTROLLING SYRINGE, Substantially Equivalent on 2008-12-17. Applicant: Maquet Cardiovascular, LLC. Device class: 1.
Clearance details
- Applicant
- Maquet Cardiovascular, LLC
- Product code
- Code GBX
- Device class
- Class 1
- Regulation
- 21 CFR 878.4200
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code GBX
view allMore clearances from Maquet Cardiovascular, LLC
view all- K252445 — Fusion Bioline Vascular Graft
- K251238 — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000) +2 more
- K243918 — Vasoview Hemopro 3 Power Supply
- K233879 — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020)
- K191930 — 7 mm Extended Length Endoscope
Adverse events under product code GBX
product code GBX- Death
- 16
- Injury
- 583
- Malfunction
- 3,578
- Other
- 1
- Total
- 4,178
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K082725
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082725.
Data sourced from openFDA. This site is unofficial and independent of the FDA.