FDA Product Code
FDA Product Code LJS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5970
510(k) Clearances — 302 records · page 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K971999 | PERIPHERALLY INSERTED CENTRAL | B.Braun Medical, Inc. | 1997-11-24 | Traditional | PDF ↗ |
| K973057 | 1.4 FR MAPCATH SENSOR STYLET | Navion Biomedical Corp. | 1997-11-12 | Traditional | PDF ↗ |
| K970926 | DOUBLE LUMEN PICC | B.Braun Medical, Inc. | 1997-08-01 | Traditional | PDF ↗ |
| K970269 | CLINICATH IR PERIPHERALLY INSERTED CATHETER | Sims Deltec, Inc. | 1997-06-26 | Traditional | PDF ↗ |
| K971085 | SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER | B.Braun Medical, Inc. | 1997-06-02 | Traditional | PDF ↗ |
| K964929 | PERIPHERALLY INSERTED CENTRAL CATHETER | B.Braun Medical, Inc. | 1997-06-02 | Traditional | PDF ↗ |
| K964556 | HR POLYURETHANE PICC AND MIDLINE CATHETERS | Johnson & Johnson Medical, Inc. | 1997-04-16 | Traditional | PDF ↗ |
| K964447 | PICC CATHETER/MIDLINE CATHETER | Menlo Care, Inc. | 1997-04-16 | Traditional | PDF ↗ |
| K970434 | NEO-PICC | Klein-Baker Medical, Inc. | 1997-04-01 | Traditional | PDF ↗ |
| K963257 | PERIPHERALLY INSERTED MEDLINE CATHETER | Arrow Intl., Inc. | 1997-03-04 | Traditional | PDF ↗ |
| K963806 | CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T) | Bmw Medical, Inc. | 1996-12-12 | Traditional | PDF ↗ |
| K963215 | CLAMPLESS VALVED CATHETER - MIDLINE (CVC-ML) | Bmw Medical, Inc. | 1996-11-14 | Traditional | PDF ↗ |
| K963097 | CLAMPLESS VALVED CATHETER-PICC (CVC-PICC) | Bmw Medical, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K962849 | CATHETER INSERTION TRAY | Medcare Medical Group, Inc. | 1996-10-07 | Traditional | PDF ↗ |
| K960055 | MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932 | Pudenz-Schulte Medical Research Corp. | 1996-09-30 | Traditional | PDF ↗ |
| K962300 | CLAMPLESS VALVED CATHETER | Bmw Medical, Inc. | 1996-09-05 | Traditional | PDF ↗ |
| K961336 | MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652 | Medtronic PS Medical | 1996-07-18 | Traditional | PDF ↗ |
| K961856 | AUTO SUTURE CHEMOSITE TUNNELER | United States Surgical, A Division of Tyco Healthc | 1996-07-18 | Traditional | PDF ↗ |
| K961155 | SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908 | Douglas Medical Products Corp. | 1996-06-18 | Traditional | PDF ↗ |
| K954302 | VYGON PREMI-CATH - LONG TERM CATHETER | Vygon Corp. | 1996-06-17 | Traditional | PDF ↗ |
| K953300 | V-CATH DUAL LUMEN E.S.P. PERIPHERAL INSERTED CENTRAL CATHETER | Hdc Corp. | 1996-04-30 | Traditional | PDF ↗ |
| K954638 | 5 FR PICC-LINE CATHETER | Vygon Corp. | 1996-04-22 | Traditional | PDF ↗ |
| K954720 | STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS | Strato/Infusaid, Inc. | 1996-01-04 | Traditional | PDF ↗ |
| K954409 | PS MEDICAL IPI VASCULAR ACCESS CATHETER | Pudenz-Schulte Medical Research Corp. | 1995-12-18 | Traditional | PDF ↗ |
| K954422 | PER-Q-CATH MID-LINE | Gesco Intl., Inc. | 1995-12-15 | Traditional | PDF ↗ |
| K954104 | PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES | C.R. Bard, Inc. | 1995-11-21 | Traditional | PDF ↗ |
| K953436 | STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER SYSTESM | Strato/Infusaid, Inc. | 1995-10-04 | Traditional | PDF ↗ |
| K953256 | STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE CENTRAL VENOUS CATHETER SYSTEMS | Strato/Infusaid, Inc. | 1995-10-04 | Traditional | PDF ↗ |
| K952626 | MAPWIRE J-TIP SENSOR GUIDEWIRE | Navion Biomedical Corp. | 1995-08-25 | Traditional | PDF ↗ |
| K951078 | CATHETER, INTRAVASCULAR OR PERCUTANEOUS | Sims Deltec, Inc. | 1995-07-31 | Traditional | PDF ↗ |
| K945956 | STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS | Strato Medical Corp. | 1995-06-06 | Traditional | PDF ↗ |
| K951098 | HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER | Hdc Corp. | 1995-06-02 | Traditional | PDF ↗ |
| K950987 | STRATO/INFUSAID TUNNELER | Strato/Infusaid, Inc. | 1995-06-02 | Traditional | PDF ↗ |
| K946250 | STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS | Strato Medical Corp. | 1995-05-02 | Traditional | PDF ↗ |
| K944685 | CATO FIRST PICC-DUAL LUMEN | Catco Medical, Inc. | 1995-03-31 | Traditional | PDF ↗ |
| K935145 | CYPERFLO PERIPHERALLY INSERTED CATHETER | Cyex Medical Technologies, Inc. | 1995-03-09 | Traditional | PDF ↗ |
| K935380 | VASCULAR ACCESS CATHETER ACCESSORIES | Bard Access Systems, Inc. | 1995-02-17 | Traditional | PDF ↗ |
| K945499 | CATO FIRST PICC KIT | Catco Medical, Inc. | 1995-02-07 | Traditional | PDF ↗ |
| K932464 | PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH. | Pharmacia Deltec, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K932198 | PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH | Pharmacia Deltec, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K932211 | PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS | Pharmacia Deltec, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K932433 | PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE | Pharmacia Deltec, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K932430 | DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER | Pharmacia Deltec, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K930473 | ONECATH L-CATH CATHETER SYSTEM | Luther Medical Products, Inc. | 1994-04-07 | Traditional | PDF ↗ |
| K930129 | ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER | Arrow Intl., Inc. | 1994-03-28 | Traditional | PDF ↗ |
| K925236 | L CATH(R) CATHETER SYSTEM | Luther Medical Products, Inc. | 1994-03-22 | Traditional | PDF ↗ |
| K926293 | ANGIOCOR SIDEHOLE INFUSION CATHETER | Angiocor | 1994-03-07 | Traditional | PDF ↗ |
| K926331 | 3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH | Bard Access Systems, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K930630 | RIGHT ATRIAL CATHETER | Akcess Medical Products, Inc. | 1994-02-07 | Traditional | PDF ↗ |
| K933884 | STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM | Strato Medical Corp. | 1993-12-30 | Traditional | PDF ↗ |
| K924851 | STRATO MEDICAL SINGLE LUMEN VALVED CATHETER | Strato Medical Corp. | 1993-12-13 | Traditional | PDF ↗ |
| K924677 | STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATH | Strato Medical Corp. | 1993-07-30 | Traditional | PDF ↗ |
| K921751 | INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER | Strato Medical Corp. | 1993-07-07 | Traditional | PDF ↗ |
| K920755 | L-CATH PEEL AWAY SYSTEM CATHETER | Luther Medical Products, Inc. | 1993-06-07 | Traditional | PDF ↗ |
| K923653 | NEEDLELESS INJECTION CANNULA | Arrow Intl., Inc. | 1993-05-13 | Traditional | PDF ↗ |
| K921755 | 8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS | Davol, Inc. | 1992-10-23 | Traditional | PDF ↗ |
| K911067 | NORCATH VASCULAR ACCESS CATHETERS | Norfolk Medical | 1991-06-03 | Traditional | PDF ↗ |
| K910486 | 8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER | Davol, Inc. | 1991-04-19 | Traditional | PDF ↗ |
| K910315 | PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K | Sorex Medical | 1991-04-05 | Traditional | PDF ↗ |
| K910622 | GESCO PER-Q-CATH REPAIR KIT | Gesco Intl., Inc. | 1991-03-29 | Traditional | PDF ↗ |
| K903648 | VYGON LIFEVAC PICC | Vygon Corp. | 1991-03-07 | Traditional | PDF ↗ |
| K904334 | PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT | Pharmacia Deltec, Inc. | 1990-11-05 | Traditional | PDF ↗ |
| K895543 | WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS CATHETER | Strato Medical Corp. | 1990-09-21 | Traditional | PDF ↗ |
| K896598 | STRATO INDWELLING CATHETER | Strato Medical Corp. | 1990-04-25 | Traditional | PDF ↗ |
| K897168 | EPICUTANEO-CAVA CATHETER CODE 2184 | Vygon Corp. | 1990-04-23 | Traditional | PDF ↗ |
| K895712 | PERCUTANEOUS INTRAVENOUS CATHETERS | Pharmacia Deltec, Inc. | 1989-12-15 | Traditional | PDF ↗ |
| K892926 | DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS | Vas-Cath, Inc. | 1989-12-05 | Traditional | PDF ↗ |
| K893126 | DESERET(R) INTRODUCER SET WITH VITACUFF(R) DEVICE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-08-10 | Traditional | PDF ↗ |
| K883313 | PMT VASCULAR CATHETER MODEL NUMBER 3621-1 | Pmt Corp. | 1988-10-04 | Traditional | PDF ↗ |
| K882448 | MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-08-09 | Traditional | PDF ↗ |
| K882100 | VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT | Vitaphore Corp. | 1988-07-13 | Traditional | PDF ↗ |
| K871998 | GROSHONG CV CATHETER REPAIR KIT | Catheter Technology Corp. | 1987-06-24 | Traditional | PDF ↗ |
| K864086 | VAPOR-SEAL(TM) PERCUTANEOUS CATHETERS | Pharmacia, Inc. | 1987-04-03 | Traditional | PDF ↗ |
| K861563 | VITAGUARD PERCUTANEOUS INFECTION CONTROL KIT | Vitaphore Corp. | 1986-08-27 | Traditional | PDF ↗ |
| K851243 | GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION | Cook, Inc. | 1986-03-14 | Traditional | PDF ↗ |
| K851195 | VASCULAR ACCESS CATHETER | Sil-Med Corp. | 1985-06-07 | Traditional | PDF ↗ |
| K844080 | ARROW-GEISS PERCUTANEOUS TPN KIT | Arrow Intl., Inc. | 1985-04-17 | Traditional | PDF ↗ |
| K843450 | ARGYLE SILICONE CENTRAL VENOUS CATH- | Sherwood Medical Co. | 1984-11-15 | Traditional | PDF ↗ |
| K841443 | REDO CENTRAL VENOUS CATHETER-NEONATE | Intl. Hospital Products, Inc. | 1984-07-27 | Traditional | PDF ↗ |
| K841878 | SHEATH REMOVER | Datascope Corp. | 1984-07-13 | Traditional | PDF ↗ |
| K840742 | RIGHT ATRIAL CATHETER | The Healthcare Group Laboratories, Inc. | 1984-07-13 | Traditional | PDF ↗ |
| K840846 | STERILE HICHMAN/BROVIAC INJECTION CAP | Evermed, Inc. | 1984-07-06 | Traditional | PDF ↗ |
| K834383 | DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT | Burron Medical Products, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K834299 | LONG TERM CENTRAL VENOUS ACCESS CATH | Burron Medical Products, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K834473 | MULTI-LUMEN CENTRAL VENOUS CATH. KIT | Burron Medical Products, Inc. | 1984-04-30 | Traditional | PDF ↗ |
| K840958 | DESERET LONG TERM INDWELLING CATHETER | Parke-Davis Co. | 1984-04-17 | Traditional | PDF ↗ |
| K840681 | DAYPAK SYSTEM III CATHETER CARE KIT | Creative Care Systems, Inc. | 1984-04-16 | Traditional | PDF ↗ |
| K833915 | VASCULAR ACCESS CATH. REPAIR KIT | Cormed, Inc., Sub. C.R.Bard, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K833442 | PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM | Quinton, Inc. | 1984-03-19 | Traditional | PDF ↗ |
| K834091 | SILCATH | Hdc Corp. | 1984-03-06 | Traditional | PDF ↗ |
| K834225 | RAAF DUAL LUMEN CATH. REPAIR KIT 2.2 | Quinton, Inc. | 1984-02-13 | Traditional | PDF ↗ |
| K831802 | LIFE VAC #2191 & 2192 | Exco, Inc. | 1984-01-11 | Traditional | PDF ↗ |
| K832580 | RAAF CATHETER REPAIR KIT | Quinton, Inc. | 1984-01-03 | Traditional | PDF ↗ |
| K832774 | REPAIR KITS FOR RIGHT ATRIAL CATH | Quinton, Inc. | 1984-01-03 | Traditional | PDF ↗ |
| K831587 | TEMP. REPAIR KIT-DUAL LUMEN CATHETER | Norton Performance Plastics Corp. | 1983-10-19 | Traditional | PDF ↗ |
| K831386 | GROSHONG CATHETER, LONG TERM TYPE | Catheter Technology Corp. | 1983-10-14 | Traditional | PDF ↗ |
| K831845 | PER-Q-CATH TRAY | Gesco Intl., Inc. | 1983-08-24 | Traditional | PDF ↗ |
| K830969 | PERM. REPAIR KIT FOR LEONARD NORTON DUAL | Norton Performance Plastics Corp. | 1983-04-14 | Traditional | PDF ↗ |
| K830256 | NON-STERILE BROVIAC PARENTERAL ALIMI- | Evermed, Inc. | 1983-03-01 | Traditional | PDF ↗ |
| K830406 | NON-STERILE CATHETER REPAIR KITS | Evermed, Inc. | 1983-03-01 | Traditional | PDF ↗ |
Product code LJS · Class II · General Hospital. Data: openFDA.