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#
- 3013557562
- 3008812560
- 3013497507
- 3015183635
- 3015859709
- 2939142
- 1061771
- 3009642126
- 9611590
- 2020550
- 2025851
- 3010400865
- 1313525
- 9610612
- 3003418325
- 3005382983
- 3008657524
- 3013764800
- 3007279848
- 3004361903
- 3006787036
- 3032912826
- 3013319212
- 3015173212
- 1420032
- 1724474
- 9615050
- 1643817
- 3007421149
- 3004727093
- 9616250
- 3017102971
- 1417592
- 2523835
- 1055236
- 3005440795
- 3004550973
- 9612030
- 1423537
- 9680721
- 3005987567
- 3014936217
- 3030078769
- 3005770916
- 1064858
- 3010155661
- 3010173425
- 3014457631
- 2027062
- 3015967359
- 8040278
- 1125782
- 3010665433
- 3004548776
- 3007007790
- 3004605321
- 1825146
- 3010621964
- 3004464325
- 3003342406
- 3017262697
- 1018233
- 3013403214
- 1721504
- 3014683120
- 3018114242
- 9681479
- 9616679
- 3030979160
- 1319211
- 3022928161
- 3023316
- 2029386
- 1045254
- 3016746538
- 1419951
- 3021821373
- 1313046
- 3009039068
- 3011137372
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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