Continu-Flo Solution W/Check Valve 2 Y-Inject Site
FDA 510(k) K873894 · Travenol Laboratories, S.A.
510(k) numberK873894
Submission
- Device name
- Continu-Flo Solution W/Check Valve 2 Y-Inject Site
- Applicant
- Travenol Laboratories, S.A.
Round Lake, IL, US - Received
- September 24, 1987
- Decision date
- November 5, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
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More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874181 | Baxter Bedside SystemFRN · Traditional | 02/22/1988SE |
| K873873 | Resubmitted Micron Transfusion FilterCAK · Traditional | 10/22/1987SE |
| K873984 | Automatic Peritoneal Dialysis Cycler Set (5C4437)KDJ · Traditional | 10/20/1987SE |
| K872364 | Hemodialysis (SPS), Model 550, Code 5M1309FII · Traditional | 10/13/1987SE |
| K872652 | Upgraded Auto Peritoneal Dialysis Cycler SystemFKX · Traditional | 09/30/1987SE |
| K870801 | Flo-Gard 6200 Volumetric Infusion/Pumping BloodFRN · Traditional | 09/04/1987SE |
| K871908 | IV Administration SetBRZ · Traditional | 07/27/1987SE |
| K871471 | Capillary Flow Dialyzers Models ST-12 & ST-15FJI · Traditional | 06/12/1987SE |
| K865029 | Continu-Flo Solution Admin. Set W/In-Line FilterFPB · Traditional | 04/17/1987SE |
| K870169 | Capillary Flow DialyzersFJI · Traditional | 04/06/1987SE |
Questions and answers
When was Continu-Flo Solution W/Check Valve 2 Y-Inject Site cleared by the FDA?
Continu-Flo Solution W/Check Valve 2 Y-Inject Site (K873894) received a 510(k) decision of Substantially Equivalent on November 5, 1987, 42 days after the submission was received.
What is the product code of K873894?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.