Cleared Traditional

K031812 - TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03

K031812 is an FDA 510(k) clearance for TRANSVAGINAL DOPPLER CLAMP, manufactured by Vascular Control Systems, Inc.. The device is a Class 2 Radiology device with product code DXC cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K031812 · Vascular Control Systems, Inc. · Radiology device
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Dec 2003
Decision
183d
Days
Class 2
Risk

K031812 is an FDA 510(k) clearance for the TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Vascular Control Systems, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on December 12, 2003 after a review of 183 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.4450 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vascular Control Systems, Inc. devices

FDA 510(k) Submission Details - K031812

510(k) Number K031812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2003
Decision Date December 12, 2003
Days to Decision 183 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 107d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - DXC Clamp, Vascular

All 122
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K031812.
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GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
K022880 · Guidant Corp. · Sep 2002