Cleared Traditional

K884491 - MEDIZIV CENTRAL VEIN CATHETER

K884491 is an FDA 510(k) clearance for MEDIZIV CENTRAL VEIN CATHETER, manufactured by Mediziv Medical Devices, Ltd.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K884491

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.

DQY Device Classification - Class 2, Special Controls

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 833
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