Transvaginal Doppler Clamp, Models: 09-0016-01, 09-0016-02, 09-0016-03
FDA 510(k) K031812 · Vascular Control Systems, Inc.
510(k) numberK031812
Submission
- Device name
- Transvaginal Doppler Clamp, Models: 09-0016-01, 09-0016-02, 09-0016-03
- Applicant
- Vascular Control Systems, Inc.
San Juan Capistrano, CA, US - Received
- June 12, 2003
- Decision date
- December 12, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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More from Vascular Graft Solutions, Ltd.
| 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 |
| K031358 | Transvaginal Doppler ProbeITX · Traditional | 05/09/2003SE |
| 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 Clamp, Models: 09-0016-01, 09-0016-02, 09-0016-03 cleared by the FDA?
Transvaginal Doppler Clamp, Models: 09-0016-01, 09-0016-02, 09-0016-03 (K031812) received a 510(k) decision of Substantially Equivalent on December 12, 2003, 183 days after the submission was received.
What is the product code of K031812?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.