Product code LDR
- Device name
- Controller, Infusion, Intravascular, Electronic
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5725
- Review panel
- HO
- 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 |
|---|---|---|---|
| K242693 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development Corporation | 2024-10-07 |
| K232316 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development | 2024-03-01 |
| K153760 | Volumetric Infusion Controller | DEKA Research & Development | 2016-10-03 |
| K963136 | PACER MODEL 100 INFUSION CONTROLLER | Health Watch, Inc. | 1997-10-10 |
| K971865 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P | Alexander Mfg. Co. | 1997-07-03 |
| K971826 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 | Alexander Mfg. Co. | 1997-07-03 |
| K934543 | UNIVERSAL CONTROLLER, MODEL 100 | Metamed, Inc. | 1994-03-29 |
| K935236 | FLOW CONTROLLING EXTENSION SET | Block Medical, Inc. | 1994-02-24 |
| K905498 | STAT 2 IV PUMPETTE | The Master Medical Corp. | 1991-04-16 |
| K905497 | MASTER FLOW I.V. PUMPETTE | The Master Medical Corp. | 1991-04-16 |
| K896907 | 3M IV FLOW REGULATOR | 3M Company | 1990-02-26 |
| K894111 | VARI-SET | Sonex Medical | 1989-09-28 |
| K894487 | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+ | Y | 1989-09-27 |
| K893487 | LIFECARE 75 CONTROLLER | Abbott Laboratories | 1989-07-28 |
| K884307 | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262 | Y | 1988-11-01 |
| K882167 | IVY COMMANDER, MODEL 600 | Ivy Medical, Inc. | 1988-09-23 |
| K880006 | STA-SET I.V. FLOW REGULATOR | Controlled Flow , Ltd. | 1988-03-24 |
| K874481 | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290 | Y | 1988-03-03 |
| K874916 | TECHNICON CHEM 1(TM) SYSTEM | Technicon Instruments Corp. | 1988-03-03 |
| K874491 | IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+ | Y | 1988-02-25 |
| K870820 | IVY COMMANDER (MODEL 500) | Ivy Medical, Inc. | 1988-01-20 |
| K870317 | IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280 | Y | 1987-04-03 |
| K870132 | IVAC FLOW CONTROL ADMINISTRATION SET | Y | 1987-02-05 |
| K864789 | BETAFLO 2000 PIGGYBACK SYSTEM | Betaflo, Inc. | 1987-02-04 |
| K864229 | STA-SET MODEL 250 I.V. FLOW REGULATOR | Sta-Set Corp. | 1986-12-16 |
| K863204 | DEKA JR. | Deka Research & Development Corp. | 1986-09-03 |
| K862273 | BETAFLO 2000 | Betaflo, Inc. | 1986-07-18 |
| K854863 | FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER | Travenol Laboratories, S.A. | 1986-02-12 |
| K855000 | RATEMINDER III INFUSION DEVICE | American Edwards Laboratories | 1986-02-12 |
| K851058 | DOSI FLOW | Leventon, S.A. | 1985-04-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08436020769153 | DOSI-FLOW | LEVENTON SAU | 2023-09-08 |
| 08436020769160 | DOSI-FLOW | LEVENTON SAU | 2023-09-08 |
| 18436020769150 | DOSI-FLOW | LEVENTON SAU | 2023-09-08 |
| 18436020769167 | DOSI-FLOW | LEVENTON SAU | 2023-09-08 |
| 08436020760099 | DOSI-FLOW | LEVENTON SAU | 2016-11-30 |
| 08436020760914 | DOSI-FLOW | LEVENTON SAU | 2016-11-30 |
| 18436020760096 | DOSI-FLOW | LEVENTON SAU | 2016-11-30 |
| 18436020760911 | DOSI-FLOW | LEVENTON SAU | 2016-11-30 |
| 00856038001096 | Iradimed | IRADIMED CORP. | 2016-08-25 |