510(k) K082725
- Device
- GRAFTGUARD PRESSURE CONTROLLING SYRINGE
- Applicant
- MAQUET CARDIOVASCULAR, LLC
- 510(k) number
- K082725
- Product code
- GBX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-12-17
- Date received
- 2008-09-17
- Regulation
- 878.4200
- Classification name
- Catheter, Irrigation
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTINA L ROWE
- Address
- 170 Baytech Dr. San Jose CA US 95134 95134
FDA Registration Numbers#
- 3030979160
- 2518902
- 3005160810
- 3004727093
- 1835959
- 2084346
- 2245304
- 3008782989
- 1000393132
- 1319639
- 3018094310
- 1054241
- 2320762
- 3015859709
- 1721504
- 1000563940
- 3003915875
- 3010400865
- 3017102971
- 3003898360
- 3007092328
- 8010099
- 3003342406
- 9616679
- 3015173212
- 3015058854
- 1526611
- 3006787036
- 3014457631
- 3016096097
- 3011642792
- 1825146
- 3009642126
- 9616088
- 3008810357
- 3006082230
- 3045058049
- 1045254
- 9612030
- 3018387313
- 3006174295
- 3040335671
- 3003974574
- 3003800209
- 3004361903
- 1017294
- 1721676
- 3009417901
- 1424263
- 3033589330
- 2020735
- 9615050
- 9610612
- 3013909820
- 1055236
- 1064858
- 3017865161
- 3034669683
- 3010621964
- 3045857302
- 9616567
- 3031184338
- 1319211
- 3007738736
- 3004548776
- 3004111573
- 3013319212
- 1643817
- 3007007790
- 1932180
- 1222168
- 3004483571
- 3042244574
- 3013764800
- 3006542380
- 9710641
- 9680837
- 3010806410
- 3004122598
- 8040278
Source Documents#
Other 510(k) Records For Product Code GBX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131659 | MOERAE VEIN PREPARATION KIT | Moerae Matrix, Inc. | 2014-03-03 |
| K052286 | DEUTSCH ANTI-BLOCKAGE WOUND DRAIN | The Catheter Exchange, Inc. | 2005-10-21 |
| K043515 | GRAFTSAVER | Vescare, Inc. | 2005-03-31 |
| K013417 | MISONIX IRRIGATION SYSTEM MOEDL BC20P | Misonix, Inc. | 2002-01-10 |
| K000704 | DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) | Dmc Medical, Ltd. | 2000-05-19 |
| K974233 | LYSONIX IRRIGATION SYSTEM | Lysonix, Inc. | 1998-02-03 |
| K973703 | JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN | Allegiance Healthcare Corp. | 1997-12-04 |
| K972635 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | 1997-10-01 |
| K965146 | FLAT CLOSED WOUND DRAIN WITH TROCAR | Axiom Medical, Inc. | 1997-03-10 |
| K961295 | SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR | Sil-Med Corp. | 1996-06-26 |
| K961147 | CLOSED FLUID COLLECTION SYSTEM | B.Braun Medical, Inc. | 1996-05-31 |
| K960955 | JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING | Baxter Healthcare Corp | 1996-05-22 |
| K955339 | HYDROLOGY 5000 | Northgate Technologies, Inc. | 1996-03-13 |
| K955474 | NEO-PNEUMOCATH | Intra Special Catheters GmbH | 1996-02-13 |
| K955505 | OPTI-DRAIN MULTI-USE DRAINAGE CATHETER | Navarre Biomedical , Ltd. | 1996-02-07 |
Legacy Summary#
summary
FDA Review#
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