510(k) K043515
- Device
- GRAFTSAVER
- Applicant
- VESCARE, INC.
- 510(k) number
- K043515
- Product code
- GBX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-03-31
- Date received
- 2004-12-20
- 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
- DAVID WALSH
- Address
- 28 Cook St. Billerica MA US 01821 01821
FDA Registration Numbers#
- 1123137
- 3017435705
- 3034669683
- 3032916632
- 3005440795
- 1825146
- 2245304
- 2320961
- 3016746538
- 3012536737
- 3030447506
- 3003342406
- 1018233
- 9680794
- 9614446
- 9710567
- 3015967359
- 1526711
- 3005382983
- 2011171
- 9612030
- 1061124
- 3009107690
- 3003761012
- 3012307300
- 8040278
- 8010099
- 3010041511
- 3017262697
- 3008810357
- 1832653
- 2640138
- 9616696
- 8030673
- 3015859709
- 1314417
- 3015173212
- 3004111573
- 3004134948
- 2437459
- 3010400865
- 3015453963
- 3010155648
- 3009642126
- 2030624
- 2939142
- 3010208880
- 1724474
- 3033589330
- 3004548776
- 1313525
- 3013764800
- 2025851
- 1064858
- 3001124136
- 2320762
- 3014457631
- 1054241
- 2124215
- 3007751444
- 3040335671
- 3027588012
- 3005483737
- 3015183635
- 3017102971
- 3007279848
- 3006617533
- 3006673317
- 1450662
- 3006128100
- 9680741
- 3014246639
- 3023316
- 1928237
- 3006260740
- 1836161
- 2029386
- 3011300255
- 3015309643
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 |
| K082725 | GRAFTGUARD PRESSURE CONTROLLING SYRINGE | Maquet Cardiovascular, LLC | 2008-12-17 |
| K052286 | DEUTSCH ANTI-BLOCKAGE WOUND DRAIN | The Catheter Exchange, Inc. | 2005-10-21 |
| 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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