Resubmitted 1,3 & 4 Way Stopcocks, Various Parts
FDA 510(k) K884435 · Clinical Connections, Inc.
510(k) numberK884435
Submission
- Device name
- Resubmitted 1,3 & 4 Way Stopcocks, Various Parts
- Applicant
- Clinical Connections, Inc.
Orrville, OH, US - Received
- October 13, 1988
- Decision date
- November 8, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMG – Stopcock, I.V. Set
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code FMG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242255 | Qitexio® 4-Way Stopcock (QIT014)FMG · Traditional | Medex | 04/29/2025SE |
| K223499 | Three Way Stop CockFMG · Traditional | M/S Romsons International | 07/21/2023SE |
| K223175 | lntravascular Administration Sets with Stopcock and ManifoldFMG · Traditional | Baxter Healthcare Corporation | 03/10/2023SE |
| K211204 | SafePort(TM) Manifold (or Stopcock)FMG · Traditional | Elcam Medical Acal | 09/15/2022SE |
| K210516 | Clicky CrossFMG · Traditional | Yomura Technologies, Inc. | 05/16/2022SE |
| K190539 | TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal…FMG · Traditional | Monumedical, LLC | 10/22/2019SE |
| K190489 | Elcam Stopcocks and ManifoldsFMG · Special | Elcam Medical Acal | 04/23/2019SE |
| K172266 | Dynarex Three-Way StopcockFMG · Traditional | Dynarex Corporation | 03/14/2018SE |
| K141254 | Elcam Stopcocks and ManifoldsFMG · Special | Elcam Medical Acal | 07/30/2014SE |
| K123084 | Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold…FMG · Traditional | Elcam Medical Acal | 05/23/2013SE |
More from Elcam Medical Acal
| 510(k) | Device | Decision |
|---|---|---|
| K871540 | Swivel Connectors #014452/#014453/#014459-120FPK · Traditional | 04/30/1987SE |
| K870325 | #014160-TAB Tubing Rotator AdaptorDTL · Traditional | 04/27/1987SE |
| K870477 | Device Connectors #000299-000 3/8 X 3/8 X 3/8 Y · Traditional | 04/03/1987SE |
| K870913 | Injection Site #014456-120FPA · Traditional | 03/17/1987SE |
| K870912 | T-Connectors 014500/014501/014502/014503-120FPK · Traditional | 03/17/1987SE |
| K870324 | #014460-120 3-WAY & #014461-120 4-WAY StopcockFMG · Traditional | 03/13/1987SE |
| K870394 | Hydrophobic #6194418/HYDRAPHILIC #6104418 FiltersFIB · Traditional | 03/03/1987SE |
| K870073 | Manifold Swivel Rotator Models 014320 & 014321-TABDTL · Traditional | 02/20/1987SE |
| K870326 | Various Luer and Tubing FittingsFPK · Traditional | 02/10/1987SE |
Questions and answers
When was Resubmitted 1,3 & 4 Way Stopcocks, Various Parts cleared by the FDA?
Resubmitted 1,3 & 4 Way Stopcocks, Various Parts (K884435) received a 510(k) decision of Substantially Equivalent on November 8, 1988, 26 days after the submission was received.
What is the product code of K884435?
The FDA product code is FMG – Stopcock, I.V. Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.