510(k) K242255
- Device
- Qitexio® 4-Way Stopcock (QIT014)
- Applicant
- Medex
- 510(k) number
- K242255
- Product code
- FMG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-29
- Date received
- 2024-07-31
- Regulation
- 880.5440
- Classification name
- Stopcock, I.V. Set
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Guylaine Casses
- Address
- 240 Allee Jacques Monod Saint-Priest FR 69800 69800
FDA Registration Numbers#
- 1000563940
- 3015173212
- 9617594
- 1423537
- 3006425876
- 2029275
- 2024024
- 1423662
- 3015085713
- 8040700
- 3033536319
- 3003704957
- 3012798826
- 1625425
- 3006891665
- 3015276780
- 8020616
- 2025816
- 1047843
- 2032112
- 3002907620
- 9616088
- 2011171
- 1319639
- 1054241
- 1928237
- 1423507
- 1018470
- 3017636737
- 2245270
- 9610847
- 3013188547
- 1220477
- 3006475220
- 3013764800
- 1055236
- 1649914
- 3004111573
- 1644312
- 2243072
- 3007344957
- 3032916632
- 9610849
- 1047429
- 1061124
- 1518293
- 3005012805
- 3013683058
- 9614279
- 1526863
- 3012410077
- 3035642068
- 2015691
- 2022435
- 1060680
- 2320762
- 1043214
- 1223004
- 3033589330
- 3009211636
- 3020778
- 1424263
- 3012809732
- 3005941719
- 3013517171
- 2032098
- 2523676
- 3010041511
- 1000324175
- 9616567
- 1713468
- 3007017524
- 9613418
- 3015309643
- 3006950086
- 9612152
- 1030451
- 3030447506
- 9615817
Source Documents#
Other 510(k) Records For Product Code FMG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K071400 | SMARTSITE STOPCOCK | Cardinal Health, Alaris Products | 2007-12-14 |