Cleared Traditional

K884491 - MEDIZIV CENTRAL VEIN CATHETER

K884491 is the FDA 510(k) clearance for MEDIZIV CENTRAL VEIN CATHETER by Mediziv Medical Devices, Ltd.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K884491 · Mediziv Medical Devices, Ltd. · Cardiovascular device
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Jun 1989
Decision
222d
Days
Class 2
Risk

K884491 is an FDA 510(k) clearance for the MEDIZIV CENTRAL VEIN CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Mediziv Medical Devices, Ltd. (Israel, IL). The FDA issued a Cleared decision on June 5, 1989 after a review of 222 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Mediziv Medical Devices, Ltd. devices

Submission Details

510(k) Number K884491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1988
Decision Date June 05, 1989
Days to Decision 222 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 125d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 483
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K884491.
USCI PROBING CATHETER
K890152 · C.R. Bard, Inc. · Aug 1989
TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE
K894084 · Target Therapeutics · Aug 1989
USCI CORONARY INFUSION CATHETER
K891069 · C.R. Bard, Inc. · Aug 1989
ACS SELECTIVE INFUSION CATHETER
K885237 · Advanced Cardiovascular Systems, Inc. · Mar 1989
ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES
K883564 · Advanced Cardiovascular Systems, Inc. · Nov 1988
MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE
K883174 · Baxter Healthcare Corp · Oct 1988