Cleared Traditional

K000830 - CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE

K000830 is an FDA 510(k) clearance for CANNULATION TOURNIQUET SET, manufactured by California Medical Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K000830 · California Medical Laboratories, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K000830

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.

DWF Device Classification - Class 2, Special Controls

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 330
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K000830.
RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET
K002019 · Sorin Group Italia S.R.L. · Mar 2001
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K003371 · Terumo Corp. · Dec 2000
QUEST MPS BACK-UP SYSYEM
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STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB
K001565 · Edwards Lifesciences, LLC · Aug 2000
STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP
K994209 · Cobe Cardiovascular, Inc. · Jun 2000
CIPA (ADULTS) CIPI (INFANTS)
K992932 · Dmc Medical, Ltd. · Jun 2000