Cleared Traditional

INTRODUCER NEEDLE (SEVERAL SIZES) (K933522) - FDA 510(k) Clearance

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

K933522 · Mediziv Medical Products 1987 , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
581d
Days
Class 2
Risk

K933522 is an FDA 510(k) clearance for the INTRODUCER NEEDLE (SEVERAL SIZES). Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Mediziv Medical Products 1987 , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on February 21, 1995 after a review of 581 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Mediziv Medical Products 1987 , Ltd. devices

Submission Details

510(k) Number K933522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1993
Decision Date February 21, 1995
Days to Decision 581 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
456d slower than avg
Panel avg: 125d · This submission: 581d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 259
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K933522.
CORDIS INTRODUCING CATHETER
K945524 · Cordis Corp. · Apr 1995
CORDIS AVANTI CATHETER SHEATH INTRODUCER
K945616 · Cordis Corp. · Mar 1995
FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET
K945396 · B.Braun Medical, Inc. · Mar 1995
BURRON CARDIOVASCULAR ANGESTAT(TM)
K931743 · B.Braun Medical, Inc. · Nov 1993
CORDIS CATHETER SHEATH INTRODUCER
K932733 · Cordis Corp. · Aug 1993
ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET
K930057 · B.Braun Medical, Inc. · Aug 1993