Smartneedle(R) Over-The-Needle Catheter
FDA 510(k) K932777 · Peripheral Systems Group
510(k) numberK932777
Submission
- Device name
- Smartneedle(R) Over-The-Needle Catheter
- Applicant
- Peripheral Systems Group
Mountain View, CA, US - Received
- June 8, 1993
- Decision date
- October 7, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code ITX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261170 | BA-004CCITX · Traditional | Fujifilm Corporation | 08/12/2026SE |
| K254143 | EM-TECH Passive Ultrasound Probe StrapITX · Traditional | EM-TECH Solutions, Inc. | 08/10/2026SE |
| K260161 | SmartGuide Disposable Guides and GridsITX · Traditional | UC-CARE , Ltd. | 07/30/2026SE |
| K262474 | ND Needle Guidance SystemITX · Traditional | Accurate Access, LLC | 07/27/2026SE |
| K261014 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 07/24/2026SE |
| K250883 | Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R)ITX · Traditional | Olympus Medical Systems Corporation | 09/18/2025SE |
| K250762 | Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R)ITX · Traditional | Olympus Medical Systems Corporation | 07/11/2025SE |
| K250524 | Mendaera Guidance SystemITX · Traditional | Mendaera, Inc. | 07/02/2025SE |
| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 06/13/2025SE |
| K241662 | Ultrasound Transducer CoverITX · Traditional | Vitrolife Sweden AB | 08/30/2024SE |
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 |
| 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 |
| K904984 | Advance 418(TM)LIT · Traditional | 04/12/1991SE |
Questions and answers
When was Smartneedle(R) Over-The-Needle Catheter cleared by the FDA?
Smartneedle(R) Over-The-Needle Catheter (K932777) received a 510(k) decision of Substantially Equivalent on October 7, 1993, 121 days after the submission was received.
What is the product code of K932777?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.