B. Braun Introcan Safety 2 IV Catheter
B. Braun Medical Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2521402 | 2521402 | B. BRAUN MEDICAL INC. | 1 | Y | 2026-01-01 | 824 12th Ave BETHLEHEM PA US 18018 |
| 3013764800 | 3013764800 | B. BRAUN MEDICAL INC. | 1 | N | 2026-01-01 | 861 Marcon Blvd. Allentown PA US 18109 |
| 1641965 | 1641965 | B. BRAUN MEDICAL INC. | 1 | N | 2020-04-25 | 1601 WALLACE DR., SUITE 150 CARROLLTON TX US 75006 |
| 2532083 | 3003218564 | B. BRAUN MEDICAL INC. | 1 | Y | 2020-04-25 | 200 BOULDER DR. BREINIGSVILLE PA US 18031 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 323539 | 1180444189 | K994375 | HORIZON LIGHT | FRN | 2000-03-08 |
| 17590 | 1385190241 | K994375 | HORIZON LIGHT | FRN | 2000-03-08 |
| 27946 | 1177748999 | K991879 | SPRING-WOUND EPIDURAL CATHETER | BSO | 1999-10-28 |
| 323539 | 1177748999 | K991879 | SPRING-WOUND EPIDURAL CATHETER | BSO | 1999-10-28 |
| 27950 | 1550036066 | K991653 | INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM | FPA | 1999-06-24 |
| 323539 | 1550036066 | K991653 | INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM | FPA | 1999-06-24 |
| 27946 | 1381479829 | K983794 | CHEMO MINI SPIKE PLUS | LHI | 1999-03-23 |
| 27950 | 1381479829 | K983794 | CHEMO MINI SPIKE PLUS | LHI | 1999-03-23 |
| 323539 | 1381479829 | K983794 | CHEMO MINI SPIKE PLUS | LHI | 1999-03-23 |
| 27946 | 1988063942 | K973322 | DIAPACT CRRT | KDI | 1998-11-10 |
| 27946 | 1050927481 | K972678 | MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS | FRN | 1997-10-07 |
| 323539 | 1331305913 | K971233 | SOFT TIP EPIDURAL CATHETER KIT | CAZ | 1997-10-17 |
| 27946 | 1410369884 | K970287 | LUMBAR PUNCTURE KIT | FMJ | 1997-04-07 |
| 323539 | 1410369884 | K970287 | LUMBAR PUNCTURE KIT | FMJ | 1997-04-07 |
| 27946 | 1055401411 | K964352 | TORQUE DEVICE | DQX | 1997-01-28 |
| 323539 | 1076189028 | K963440 | DIALOG DIALYSIS MACHINE | KDI | 1998-06-26 |
| 27946 | 1076189028 | K963440 | DIALOG DIALYSIS MACHINE | KDI | 1998-06-26 |
| 323539 | 1644974086 | K962696 | PERIFIX PEDIATRIC EPIDURAL KIT | CAZ | 1997-04-03 |
| 323539 | 1652904157 | K961147 | CLOSED FLUID COLLECTION SYSTEM | GBX | 1996-05-31 |
| 27946 | 1652904157 | K961147 | CLOSED FLUID COLLECTION SYSTEM | GBX | 1996-05-31 |
| 323539 | 1822672465 | K960674 | CONTRAST INJECTION LINES | DXT | 1996-09-19 |
| 27946 | 1822672465 | K960674 | CONTRAST INJECTION LINES | DXT | 1996-09-19 |
| 27946 | 2024054909 | K955585 | V2 INJECTION SITE | FPA | 1996-05-15 |
| 323539 | 2024054909 | K955585 | V2 INJECTION SITE | FPA | 1996-05-15 |
| 27946 | 1617280318 | K955179 | CONTRAST MEDIA SET | IZI | 1997-03-12 |
| 323539 | 1617280318 | K955179 | CONTRAST MEDIA SET | IZI | 1997-03-12 |
| 323539 | 1735178447 | K954123 | LOW PROFILE SAFSITE Y-SITE | FPA | 1995-11-21 |
| 27946 | 1735178447 | K954123 | LOW PROFILE SAFSITE Y-SITE | FPA | 1995-11-21 |
| 27950 | 1782497238 | K952810 | DOSI-FLOW, MODELS 20 & 30 | FPA | 1995-09-08 |
| 323539 | 1995996641 | K952631 | BRAUN HEMODIALYSIS BLOOD CIRCUITS | FJK | 1996-04-30 |
| 27946 | 1995996641 | K952631 | BRAUN HEMODIALYSIS BLOOD CIRCUITS | FJK | 1996-04-30 |
| 27946 | 1654356339 | K943770 | LOW VOLUME MULTIPORT | FPA | 1995-04-10 |
| 323539 | 1654356339 | K943770 | LOW VOLUME MULTIPORT | FPA | 1995-04-10 |
| 323539 | 1591390809 | K943181 | DISPENSING PIN WITH ONE-WAY VALVE | LHI | 1994-09-29 |
| 27946 | 1591390809 | K943181 | DISPENSING PIN WITH ONE-WAY VALVE | LHI | 1994-09-29 |
| 323539 | 1344947180 | K942988 | FILTERED EXTENSION SETS | FPA | 1995-07-14 |
| 27946 | 1344947180 | K942988 | FILTERED EXTENSION SETS | FPA | 1995-07-14 |
| 27946 | 1299145307 | K942391 | BRAUN MANIFOLD | DTL | 1995-06-21 |
| 323539 | 1032784921 | K941589 | SYRINGE FILTER DEVICES | FMF | 1994-09-06 |
| 27950 | 1032784921 | K941589 | SYRINGE FILTER DEVICES | FMF | 1994-09-06 |
| 27946 | 1503004029 | K932400 | ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY | BSP | 1993-12-13 |
| 323539 | 1503004029 | K932400 | ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY | BSP | 1993-12-13 |
| 27946 | 1781949044 | K931377 | SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT | FPA | 1994-03-07 |
| 323539 | 1781949044 | K931377 | SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT | FPA | 1994-03-07 |
| 27946 | 1139091498 | K925401 | IV FLUID TRANSFER PIN | LHI | 1993-03-03 |
| 323539 | 1139091498 | K925401 | IV FLUID TRANSFER PIN | LHI | 1993-03-03 |
| 323539 | 1107030394 | K922637 | HORIZON PUMP Y-TYPE BLOOD SET | FPA | 1993-06-04 |
| 27946 | 1107030394 | K922637 | HORIZON PUMP Y-TYPE BLOOD SET | FPA | 1993-06-04 |
| 27946 | 1461918154 | K921860 | MODIFICATION TO IV SPIKE | FPA | 1992-07-30 |
| 323539 | 1461918154 | K921860 | MODIFICATION TO IV SPIKE | FPA | 1992-07-30 |
| 27946 | 1338169650 | K915421 | GUIDEWIRE INTRODUCER SET | DYB | 1992-02-27 |
| 323539 | 1338169650 | K915421 | GUIDEWIRE INTRODUCER SET | DYB | 1992-02-27 |
| 27946 | 1972283386 | K913661 | MODIFIED VOLUMETRIC INFUSION PUMP | FRN | 1991-12-18 |
| 323539 | 1972283386 | K913661 | MODIFIED VOLUMETRIC INFUSION PUMP | FRN | 1991-12-18 |
| 323539 | 1155815642 | K904518 | VOLUMETRIC INFUSION PUMP | FRN | 1990-10-17 |
| 27946 | 1155815642 | K904518 | VOLUMETRIC INFUSION PUMP | FRN | 1990-10-17 |
| 27946 | 1128822499 | K903809 | PROTECTED NEEDLE WITH OR WITHOUT IV SET | FPA | 1990-10-03 |
| 323539 | 1128822499 | K903809 | PROTECTED NEEDLE WITH OR WITHOUT IV SET | FPA | 1990-10-03 |
| 323539 | 1274350698 | K902409 | BECTON DICKINSON 360 INFUSER (TM) SYSTEM | FRN | 1990-07-19 |
| 27946 | 1274350698 | K902409 | BECTON DICKINSON 360 INFUSER (TM) SYSTEM | FRN | 1990-07-19 |
| 27946 | 1934654556 | K900865 | ADD-A-VIAL II BINARY CONNECTOR | LHI | 1990-07-11 |
| 323539 | 1934654556 | K900865 | ADD-A-VIAL II BINARY CONNECTOR | LHI | 1990-07-11 |
| 323539 | 1728501480 | K895580 | Y-ADAPTER W/THOUY BORST | DYB | 1990-04-30 |
| 27946 | 1728501480 | K895580 | Y-ADAPTER W/THOUY BORST | DYB | 1990-04-30 |
| 27946 | 1648400442 | K895109 | SECONDARY IV SET WITH PROTECTED NEEDLE | FPA | 1989-09-27 |
| 323539 | 1648400442 | K895109 | SECONDARY IV SET WITH PROTECTED NEEDLE | FPA | 1989-09-27 |
| 323539 | 1501469905 | K894446 | ANGEION HEMOSTASIS VALVE INTRODUCER | DYB | 1989-11-30 |
| 27946 | 1501469905 | K894446 | ANGEION HEMOSTASIS VALVE INTRODUCER | DYB | 1989-11-30 |
| 323539 | 1027906936 | K884183 | BURRON TEFLON-COATED GUIDEWIRE | DQX | 1989-08-03 |
| 27946 | 1027906936 | K884183 | BURRON TEFLON-COATED GUIDEWIRE | DQX | 1989-08-03 |
| 27950 | 2012348778 | K875196 | DISPOSABLE CORONARY CONTROL SYRINGE 12CC | DXT | 1988-02-11 |
| 323539 | 1744744491 | K871153 | CATHETER INTRODUCER | DYB | 1987-06-24 |
| 27946 | 1744744491 | K871153 | CATHETER INTRODUCER | DYB | 1987-06-24 |
| 27950 | 1799975683 | K860126 | STIMUPLEX, NERVE STIMULATOR | BXN | 1986-02-28 |
| 323539 | 1799975683 | K860126 | STIMUPLEX, NERVE STIMULATOR | BXN | 1986-02-28 |
| 27946 | 1412746649 | K853014 | MCGHAN TISSUE EXPANDER FILL KIT | LCJ | 1985-09-18 |
| 323539 | 1412746649 | K853014 | MCGHAN TISSUE EXPANDER FILL KIT | LCJ | 1985-09-18 |
| 27950 | 1554310844 | K851058 | DOSI FLOW | LDR | 1985-04-29 |
| 323539 | 1473523356 | K844719 | 360 INFUSER | FRN | 1985-01-28 |
| 27946 | 1473523356 | K844719 | 360 INFUSER | FRN | 1985-01-28 |
| 27946 | 2039516873 | K841639 | NOVA BALLOON THERMODILUTION CATH. | DYG | 1984-08-12 |
| 323539 | 2039516873 | K841639 | NOVA BALLOON THERMODILUTION CATH. | DYG | 1984-08-12 |
| 323539 | 1535828721 | K840388 | PAB IV CONTAINER | KPE | 1984-03-06 |
| 27946 | 1535828721 | K840388 | PAB IV CONTAINER | KPE | 1984-03-06 |
| 27946 | 1106584795 | K840287 | BRACHIAL PLEXUS ANESTHESIA TRAY | CAZ | 1984-02-23 |
| 323539 | 1106584795 | K840287 | BRACHIAL PLEXUS ANESTHESIA TRAY | CAZ | 1984-02-23 |
| 27946 | 1865627798 | K840212 | CONCENTRATED PLATELET ADMIN. SET | FPA | 1984-03-06 |
| 323539 | 1865627798 | K840212 | CONCENTRATED PLATELET ADMIN. SET | FPA | 1984-03-06 |
| 27946 | 1971477606 | K840179 | CONTINUOUS EPIDURAL ANESTHES. TRAY | CAZ | 1984-02-24 |
| 323539 | 1971477606 | K840179 | CONTINUOUS EPIDURAL ANESTHES. TRAY | CAZ | 1984-02-24 |
| 27946 | 1305368617 | K822806 | BALLOON WEDGE PRESSURE, ANGIOGRAPHIC | DYG | 1982-11-01 |
| 323539 | 1305368617 | K822806 | BALLOON WEDGE PRESSURE, ANGIOGRAPHIC | DYG | 1982-11-01 |
| 323539 | 1278095072 | K820454 | THE RED CAP | FMF | 1982-03-08 |
| 27946 | 1278095072 | K820454 | THE RED CAP | FMF | 1982-03-08 |
| 27946 | 1936700375 | K820453 | THE INT-STOPPER | FPA | 1982-03-08 |
| 323539 | 1936700375 | K820453 | THE INT-STOPPER | FPA | 1982-03-08 |
| 323539 | 1338339833 | K820047 | SPINOCAN SPINAL NEEDLE | BSP | 1982-01-25 |
| 27950 | 1338339833 | K820047 | SPINOCAN SPINAL NEEDLE | BSP | 1982-01-25 |
| 323539 | 1806225102 | K813186 | PERFIX SET FOR EPIDURAL ANESTHESIA W/TUO | CAZ | 1981-12-03 |
| 27946 | 2029993828 | K813092 | ACCUPRO I.V. ADMINISTRATION SET | FPA | 1981-12-31 |
| 323539 | 2029993828 | K813092 | ACCUPRO I.V. ADMINISTRATION SET | FPA | 1981-12-31 |
| 27946 | 1963111012 | K810460 | BURRON PERCUTANEOUS INDUCER SET | DQY | 1981-03-11 |
| 323539 | 1963111012 | K810460 | BURRON PERCUTANEOUS INDUCER SET | DQY | 1981-03-11 |
| 323539 | 1175287391 | K801311 | BURRON MULTI-AD SYRINGE CAP | FMF | 1980-06-17 |
| 27946 | 1175287391 | K801311 | BURRON MULTI-AD SYRINGE CAP | FMF | 1980-06-17 |
| 323539 | 1749100232 | K801108 | DOUBLE ENDED VENTED TRANSFER DEVICE | FMI | 1980-05-30 |
| 27946 | 1749100232 | K801108 | DOUBLE ENDED VENTED TRANSFER DEVICE | FMI | 1980-05-30 |
| 323539 | 1100663452 | K801107 | DOUBLE ENDED FILTERED TRANSFER NEEDLE | FMI | 1980-05-30 |
| 27946 | 1100663452 | K801107 | DOUBLE ENDED FILTERED TRANSFER NEEDLE | FMI | 1980-05-30 |
| 27946 | 1461978515 | K800437 | SYRINGE TIP CONNECTOR | KYX | 1980-03-12 |
| 323539 | 1461978515 | K800437 | SYRINGE TIP CONNECTOR | KYX | 1980-03-12 |
| 27946 | 1753853675 | K792227 | MULTI-AD FLUID DISPENSING SYSTEM | KYX | 1979-12-20 |
| 323539 | 1753853675 | K792227 | MULTI-AD FLUID DISPENSING SYSTEM | KYX | 1979-12-20 |
| 323539 | 1177415011 | K790062 | IV ADMINISTRATION SET WITH BACKCHECK | FPA | 1979-04-10 |
| 27946 | 1177415011 | K790062 | IV ADMINISTRATION SET WITH BACKCHECK | FPA | 1979-04-10 |
| 27946 | 1098121324 | K781744 | IV SET WITH GRADUATED CHAMBER | FPA | 1978-12-07 |
| 323539 | 1098121324 | K781744 | IV SET WITH GRADUATED CHAMBER | FPA | 1978-12-07 |
| 323539 | 1837093299 | K780551 | I.V. ADMINISTRATION SET WITH MINI-SPIKE | FPA | 1978-04-19 |
| 27946 | 1837093299 | K780551 | I.V. ADMINISTRATION SET WITH MINI-SPIKE | FPA | 1978-04-19 |
| 323539 | 1237015794 | K760392 | SYRINGES | FMF | 1976-11-02 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FPA | 66 | 2025-07-24 |
| FRN | 28 | 2018-06-12 |
| LHI | 19 | 2020-12-09 |
| FMF | 13 | 2020-03-05 |
| CAZ | 13 | 2012-01-24 |
| DYB | 11 | 2003-07-15 |
| FMI | 10 | 2018-06-11 |
| FOZ | 9 | 2024-07-26 |
| KDI | 9 | 2017-08-11 |
| BSP | 8 | 2020-05-27 |
| KPO | 8 | 2011-04-25 |
| KPE | 8 | 2008-03-12 |
| ONB | 7 | 2025-08-05 |
| FRO | 7 | 2017-05-23 |
| BSO | 6 | 2023-09-15 |
| FMG | 6 | 2022-09-15 |
| BXN | 5 | 2007-03-22 |
| FIP | 4 | 2023-08-16 |
| MRZ | 4 | 2020-03-12 |
| FJK | 4 | 2008-07-18 |
| DYG | 4 | 1984-08-12 |
| KYX | 4 | 1980-03-12 |
| DQX | 3 | 1997-01-28 |
| DXT | 3 | 1996-09-19 |
| DTK | 2 | 2024-07-31 |
| GBM | 2 | 2018-11-05 |
| PTI | 2 | 2017-11-03 |
| GCB | 2 | 2015-11-12 |
| MEA | 2 | 2009-11-04 |
| MEB | 2 | 2008-07-15 |
| FKQ | 2 | 2006-06-09 |
| FMJ | 2 | 1997-04-07 |
| IZI | 2 | 1997-03-12 |
| GBX | 2 | 1996-05-31 |
| LCJ | 2 | 1985-09-18 |
| DQY | 2 | 1981-03-11 |
| KGZ | 2 | 1976-11-02 |
| JCY | 2 | 1976-11-02 |
| DQO | 2 | 1976-11-02 |
| QEH | 1 | 2024-07-13 |
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.