510(k) K961147
- Device
- CLOSED FLUID COLLECTION SYSTEM
- Applicant
- B. BRAUN MEDICAL, INC.
- 510(k) number
- K961147
- Product code
- GBX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-05-31
- Date received
- 1996-03-21
- 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
- MARK S ALSBERGE
- Address
- 824 Twelfth Ave. Bethlehem PA US 18018 18018
FDA Registration Numbers#
- 1000523114
- 3016096097
- 9614446
- 3030078769
- 1420032
- 3013403214
- 3023316
- 9681867
- 3030446844
- 3032912826
- 2648045
- 3006260740
- 3009039068
- 3001124136
- 3003903031
- 1480288
- 2320961
- 1820334
- 1828288
- 3005699784
- 3004464325
- 3012421607
- 1018470
- 1000112137
- 3007007790
- 1313046
- 3013557562
- 2640138
- 3032916632
- 3007421149
- 9616250
- 2020735
- 3015225571
- 3022928161
- 3005327291
- 3040335671
- 8010099
- 3006082230
- 1721504
- 3010806410
- 3003418325
- 3014683120
- 3006617533
- 3009107690
- 3010452421
- 3030979160
- 1314417
- 1420054
- 3007305485
- 3014936217
- 8040278
- 9680794
- 2025851
- 2210968
- 2011171
- 1423662
- 3031783617
- 2029015
- 1835959
- 9610612
- 3006128100
- 3008810357
- 3008782989
- 1526711
- 3004472854
- 2245304
- 1319660
- 3003915875
- 3004134948
- 3018114242
- 1450662
- 3017435705
- 1424263
- 1928237
- 9710567
- 3010202439
- 3011642792
- 3007279848
- 3010400865
- 9611590
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 |
| 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 |
| 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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