Product code JCY
- Device name
- Catheter, Infusion
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4200
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K863982 | VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY | Vas-Cath of Canada , Ltd. | 1986-10-24 |
| K840324 | SILICONE SUMP DRAIN 20 & 40 FRENCH | Superior Plastic Products Corp. | 1984-04-25 |
| K834615 | TRIPLE LUMEN INFUSIONCATHETERS- | Medical Components, Inc. | 1984-02-14 |
| K831453 | SILCATH CENTRAL CATHETER TRAY W/18 GA | Argon Medical Corp. | 1983-07-28 |
| K831451 | SILCATH CENTRAL CATHETER TRAY SIZE- | Argon Medical Corp. | 1983-06-08 |
| K822096 | CHEMOTHERAPY INFUSION CATHETER | American Heyer Schulte | 1983-04-12 |
| K813606 | SILICONE ELASTOMER INFUSION CATHETER | Quest Medical, Inc. | 1982-01-18 |
| K791372 | JELCO & KVO CATHETER PLACEMENT UNIT | Jelco Laboratories | 1979-09-12 |
| K771861 | CATHETER, CEBTRAL VENOUS, 2N1501 | Travenol Laboratories, S.A. | 1977-11-28 |
| K760760 | CATHETER, INTRAVASCULAR (ARGYLE IV SK) | Sherwood Medical Industries | 1976-12-09 |
| K760380 | INTRAVENOUS TRANSFER SET (INTRAFIX) | B. Braun Instruments | 1976-11-02 |
| K760381 | BLOOD TRANSFUSION SET (SANGOFIX) | B. Braun Instruments | 1976-11-02 |
| K760390 | CATHETER, VEIN (BRAUNULA T) | B. Braun Instruments | 1976-11-02 |
| K760391 | CATHETER, VEIN (BRAUNULA) | B. Braun Instruments | 1976-11-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10680651385250 | Halyard | O&M HALYARD, INC. | 2023-07-31 |
| 30680651385254 | Halyard | O&M HALYARD, INC. | 2023-07-31 |
| 00884908175646 | TRIPLE LUMEN INFUSION CATHETERS | Medical Components, Inc. | 2023-06-17 |
| 50884908175641 | TRIPLE LUMEN INFUSION CATHETERS | Medical Components, Inc. | 2023-06-17 |
| 06974567743462 | EMSRUN | Wuxi Emsrun Technology Co., Ltd. | 2022-12-06 |
| 50884908147068 | N/AN/A | Medical Components, Inc. | 2019-10-02 |
| 50884908147051 | N/AN/A | Medical Components, Inc. | 2019-10-02 |
| 00884908147056 | N/AN/A | Medical Components, Inc. | 2019-10-02 |
| 00884908147063 | N/AN/A | Medical Components, Inc. | 2019-10-02 |
| 00884908147070 | N/AN/A | Medical Components, Inc. | 2019-10-02 |
| 50884908147075 | N/AN/A | Medical Components, Inc. | 2019-10-02 |
| 00884908146394 | INFUSION CATHETERINFUSION CATHETER | Medical Components, Inc. | 2019-07-30 |
| 50884908146436 | INFUSION CATHETERINFUSION CATHETER | Medical Components, Inc. | 2019-07-30 |
| 50884908146429 | INFUSION CATHETERINFUSION CATHETER | Medical Components, Inc. | 2019-07-30 |
| 50884908146412 | INFUSION CATHETERINFUSION CATHETER | Medical Components, Inc. | 2019-07-30 |
| 50884908146405 | INFUSION CATHETERINFUSION CATHETER | Medical Components, Inc. | 2019-07-30 |
| 50884908146399 | INFUSION CATHETERINFUSION CATHETER | Medical Components, Inc. | 2019-07-30 |
| 00884908146400 | INFUSION CATHETERINFUSION CATHETER | Medical Components, Inc. | 2019-07-30 |
| 00884908146431 | INFUSION CATHETERINFUSION CATHETER | Medical Components, Inc. | 2019-07-30 |
| 00884908146424 | INFUSION CATHETERINFUSION CATHETER | Medical Components, Inc. | 2019-07-30 |
| 00884908146417 | INFUSION CATHETERINFUSION CATHETER | Medical Components, Inc. | 2019-07-30 |
| 50884908029043 | N/AN/A | Medical Components, Inc. | 2019-07-02 |
| 00884908029048 | N/AN/A | Medical Components, Inc. | 2019-07-02 |
| 00884908097009 | TRIPLE LUMEN INFUSION CATHETERSTRIPLE LUMEN INFUSION CATHETERS | Medical Components, Inc. | 2017-03-16 |
| 50884908097004 | TRIPLE LUMEN INFUSION CATHETERSTRIPLE LUMEN INFUSION CATHETERS | Medical Components, Inc. | 2017-03-16 |
| 04046964189555 | Blood Spike Adapter | B. BRAUN MEDICAL INC. | 2016-09-23 |