510(k) K911415
- Device
- TRUMPET VALVE
- Applicant
- B. BRAUN OF AMERICA, INC.
- 510(k) number
- K911415
- Product code
- FMG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-06-03
- Date received
- 1991-04-01
- Regulation
- 880.5440
- Classification name
- Stopcock, I.v. Set
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code FMG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242255 | Qitexio® 4-Way Stopcock (QIT014) | Medex | 2025-04-29 |
| K223499 | Three Way Stop Cock | M/S Romsons International | 2023-07-21 |
| K223175 | lntravascular Administration Sets with Stopcock and Manifold | Baxter Healthcare Corporation | 2023-03-10 |
| K211204 | SafePort(TM) Manifold (or Stopcock) | Elcam Medical Acal | 2022-09-15 |
| K210516 | Clicky Cross | Yomura Technologies, Inc. | 2022-05-16 |
| K190539 | TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile | Monumedical, LLC | 2019-10-22 |
| K190489 | Elcam Stopcocks and Manifolds | Elcam Medical Acal | 2019-04-23 |
| K172266 | Dynarex Three-Way Stopcock | Dynarex Corporation | 2018-03-14 |
| K141254 | ELCAM STOPCOCKS AND MANIFOLDS | Elcam Medical Acal | 2014-07-30 |
| K123084 | DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD | Elcam Medical Acal | 2013-05-23 |
| K130245 | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO | Baxter Healthcare Corp | 2013-03-01 |
| K082110 | DUAL SYRINGE HOLDER | Surgin Surgical Instrumentation, Inc. | 2009-06-17 |
| K082836 | ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES | Icu Medical, Inc. | 2009-02-25 |
| K082106 | ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) | Elcam Medical Acal | 2008-10-02 |
| K080077 | CLAVE STOPCOCK | Icu Medical, Inc. | 2008-02-13 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases