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#
- 3017262697
- 3004468406
- 3015173212
- 1000563940
- 1423537
- 1061771
- 3003898360
- 2029275
- 3006128100
- 1526611
- 9614446
- 3014457631
- 9610612
- 2242352
- 2244478
- 9680837
- 3004134948
- 3034669683
- 9616991
- 3011642792
- 1423662
- 3017865161
- 2939142
- 1057421
- 3010400865
- 3004483571
- 9616250
- 3017435705
- 3007305485
- 3007421149
- 3005699784
- 3003974574
- 1420054
- 2025851
- 1119193
- 3006260740
- 3005067367
- 3010202439
- 1047843
- 9616088
- 3018094310
- 3005987567
- 2011171
- 9680741
- 3010331645
- 3032912826
- 3014246639
- 3009642126
- 3021821373
- 8030673
- 1319639
- 1018233
- 3004608878
- 1054241
- 9610632
- 2245304
- 1835959
- 1928237
- 3007279848
- 3004472854
- 3003915875
- 3040335671
- 1018470
- 1064858
- 1313046
- 9615050
- 3005327291
- 3003761012
- 3008812560
- 3013497507
- 3015183635
- 3015231789
- 3009107690
- 2029015
- 1222168
- 3010273872
- 1921846
- 3005483737
- 3030979160
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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