PSG Hemostatic Control Valve
FDA 510(k) K904959 · Peripheral Systems Group
510(k) numberK904959
Submission
- Device name
- PSG Hemostatic Control Valve
- Applicant
- Peripheral Systems Group
Mountain View, CA, US - Received
- November 5, 1990
- Decision date
- December 17, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| K940804 | Smartneedle Vascular Access System, ModificationITX · Traditional | 06/10/1994SE |
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| K932777 | Smartneedle(R) Over-The-Needle CatheterITX · Traditional | 10/07/1993SE |
| K931327 | PSG Directional Hydrophilic Guide WireDQX · Traditional | 07/14/1993SE |
| K915554 | Hi-Torque Sport-T(Tm) Guide WireDQX · Traditional | 02/09/1993SE |
| K914979 | Edm(R) Infusion CatheterKRA · Traditional | 09/16/1992SE |
| K913941 | Psg(Tm) 20 Guage Doppler NeedleITX · Traditional | 02/27/1992SE |
| K915168 | Proflex 5LIT · Traditional | 02/19/1992SE |
| K913477 | Apex(Tm) Prostatic Balloon Dilation CatheterKOE · Traditional | 12/27/1991SE |
| K913746 | Smartneedle(Tm) Vascular Access SystemITX · Traditional | 12/17/1991SE |
Questions and answers
When was PSG Hemostatic Control Valve cleared by the FDA?
PSG Hemostatic Control Valve (K904959) received a 510(k) decision of Substantially Equivalent on December 17, 1990, 42 days after the submission was received.
What is the product code of K904959?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.