510(k) K031812
K031812 is an FDA 510(k) premarket notification submitted by Vascular Control Systems, Inc. for the device "TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03". The FDA issued a decision of Substantially Equivalent on December 12, 2003. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Vascular Control Systems, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2003
- Date Received
- June 12, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type