Transvaginal Doppler Probe
FDA 510(k) K031358 · Vascular Control Systems, Inc.
510(k) numberK031358
Submission
- Device name
- Transvaginal Doppler Probe
- Applicant
- Vascular Control Systems, Inc.
San Juan Capistrano, CA, US - Received
- April 30, 2003
- Decision date
- May 9, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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More from Vitrolife Sweden AB
| 510(k) | Device | Decision |
|---|---|---|
| K060573 | Burbank TenaculumHDC · Traditional | 04/21/2006SE |
| K052209 | VCS Doppler Transceiver, Model 09-0023-01DPW · Traditional | 09/06/2005SE |
| K032125 | Cstat, Models 09-0014-01 and 09-0014-02DXC · Traditional | 02/09/2004SE |
| K031812 | Transvaginal Doppler Clamp, Models: 09-0016-01, 09-0016-02, 09-0016-03DXC · Traditional | 12/12/2003SE |
| K030078 | Burbank Tenaculum, Model 09-0011-01HDC · Traditional | 01/24/2003SE |
| K023154 | Vcs-A Series Clamp with Doppler Ultrasound, Model 09-0007-01 and 09-0007-02DXC · Traditional | 12/20/2002SE |
| K023024 | Transvaginal Doppler Probe, Model 09-0006-02ITX · Traditional | 09/26/2002SE |
| K011863 | Vcs-A Series ClampDXC · Traditional | 02/15/2002SE |
Questions and answers
When was Transvaginal Doppler Probe cleared by the FDA?
Transvaginal Doppler Probe (K031358) received a 510(k) decision of Substantially Equivalent on May 9, 2003, 9 days after the submission was received.
What is the product code of K031358?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.