Arteriogram Tray
FDA 510(k) K812927 · American Pharmaseal Div. Ahsc
510(k) numberK812927
Submission
- Device name
- Arteriogram Tray
- Applicant
- American Pharmaseal Div. Ahsc
Mchenry, IL, US - Received
- October 19, 1981
- Decision date
- November 6, 1981
- 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 |
|---|---|---|
| K874022 | Pharmaseal Wound Irrigation DeviceFQH · Traditional | 12/30/1987SE |
| K874517 | Pharmaseal Rubber Urethral CatheterKOD · Traditional | 12/03/1987SE |
| K874045 | Pharmaseal Endoscopy Prep Kit Upper and LowerNWU · Traditional | 12/03/1987SE |
| K873359 | Airlife Volume Venti. Circuit W/Clear Cap Ex ValveCAI · Traditional | 11/06/1987SE |
| K872228 | Pharmaseal Alternating Pressure Pad SystemFNM · Traditional | 09/04/1987SE |
| K872917 | Jinotti Suction/Oxygen Insufflation CatheterBSY · Traditional | 08/11/1987SE |
| K871429 | Antimicrobial Foley CatheterKOD · Traditional | 08/10/1987SE |
| K871770 | American Pharmaseal Wound DressingFRO · Traditional | 06/26/1987SN |
| K870387 | Euromedical, Endosoft Endotracheal TubeBTR · Traditional | 05/08/1987SE |
| K870977 | Pharmaseal T Type Thermocouple 100% Cath./ProbeKOD · Traditional | 04/01/1987SE |
Questions and answers
When was Arteriogram Tray cleared by the FDA?
Arteriogram Tray (K812927) received a 510(k) decision of Substantially Equivalent on November 6, 1981, 18 days after the submission was received.
What is the product code of K812927?
The FDA product code is FMG – Stopcock, I.V. Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.