Smartneedle(Tm) Vascular Access System
FDA 510(k) K913746 · Peripheral Systems Group
510(k) numberK913746
Submission
- Device name
- Smartneedle(Tm) Vascular Access System
- Applicant
- Peripheral Systems Group
Mountain View, CA, US - Received
- August 21, 1991
- Decision date
- December 17, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Vitrolife Sweden AB
| 510(k) | Device | Decision |
|---|---|---|
| K940804 | Smartneedle Vascular Access System, ModificationITX · Traditional | 06/10/1994SE |
| K934433 | Vantage Dialtaion CatheterLIT · Traditional | 12/09/1993SE |
| 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 |
| K904984 | Advance 418(TM)LIT · Traditional | 04/12/1991SE |
Questions and answers
When was Smartneedle(Tm) Vascular Access System cleared by the FDA?
Smartneedle(Tm) Vascular Access System (K913746) received a 510(k) decision of Substantially Equivalent on December 17, 1991, 118 days after the submission was received.
What is the product code of K913746?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.