Cleared Traditional

CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE (K000830) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K000830 · California Medical Laboratories, Inc. · Cardiovascular device
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Sep 2000
Decision
177d
Days
Class 2
Risk

K000830 is an FDA 510(k) clearance for the CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by California Medical Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on September 7, 2000 after a review of 177 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - the FDA cardiovascular device 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all California Medical Laboratories, Inc. devices

Submission Details

510(k) Number K000830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2000
Decision Date September 07, 2000
Days to Decision 177 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 125d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 105
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K000830.
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MADTRONIC DLP ARTERIAL CANNULAE
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K932208 · Baxter Healthcare Corp · Aug 1994