Graftguard Pressure Controlling Syringe
FDA 510(k) K082725 · Maquet Cardiovascular, LLC
510(k) numberK082725
Submission
- Device name
- Graftguard Pressure Controlling Syringe
- Applicant
- Maquet Cardiovascular, LLC
San Jose, CA, US - Received
- September 17, 2008
- Decision date
- December 17, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GBX – Catheter, Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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| K131659 | Moerae Vein Preparation KitGBX · Traditional | Moerae Matrix, Inc. | 03/03/2014SE |
| K052286 | Deutsch Anti-Blockage Wound DrainGBX · Traditional | The Catheter Exchange, Inc. | 10/21/2005SE |
| K043515 | GraftsaverGBX · Traditional | Vescare, Inc. | 03/31/2005SE |
| K013417 | Misonix Irrigation System Moedl BC20PGBX · Traditional | Misonix, Inc. | 01/10/2002SE |
| K000704 | DMC Saphenous Vein Distention System (SVDS)GBX · Traditional | Dmc Medical, Ltd. | 05/19/2000SE |
| K974233 | Lysonix Irrigation SystemGBX · Traditional | Lysonix, Inc. | 02/03/1998SE |
| K973703 | Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound DrainGBX · Traditional | Allegiance Healthcare Corp. | 12/04/1997SE |
| K972635 | Ultracell Suction SpongeGBX · Traditional | Ultracell Medical Technologies, Inc. | 10/01/1997SE |
| K965146 | Flat Closed Wound Drain with TrocarGBX · Traditional | Axiom Medical, Inc. | 03/10/1997SE |
| K961295 | Sapphire Line Flat Drain/Kit with Spi-Argent II W/Or W/Out TrocarGBX · Traditional | Sil-Med Corp. | 06/26/1996SE |
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| K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3…GEI · Traditional | 02/27/2024SE |
| K191930 | 7 mm Extended Length EndoscopeGCJ · Traditional | 04/15/2020SE |
| K191947 | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension…GEI · Traditional | 09/17/2019SE |
| K153194 | VASOVIEW HemoPro Endoscopic Vessel Harvesting SystemGEI · Traditional | 04/19/2016SE |
| K153523 | FUSION Vascular GraftDSY · Traditional | 02/16/2016SE |
| K132743 | Harvesting CannulaGEI · Traditional | 12/03/2013SE |
| K131778 | Fusion Vascular Graft and Fusion Bioline Vascular GraftDSY · Traditional | 11/14/2013SE |
Questions and answers
When was Graftguard Pressure Controlling Syringe cleared by the FDA?
Graftguard Pressure Controlling Syringe (K082725) received a 510(k) decision of Substantially Equivalent on December 17, 2008, 91 days after the submission was received.
What is the product code of K082725?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.