Cleared Traditional

K020964 - NEICH NM ADVANCE CATHETER SHEATH INTRODUCER

K020964 is an FDA 510(k) clearance for NEICH NM ADVANCE CATHETER SHEATH INTRODUCER, manufactured by Neich Medical(Shenzhen)Company, Ltd.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K020964 · Neich Medical(Shenzhen)Company, Ltd. · Cardiovascular device
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Oct 2002
Decision
200d
Days
Class 2
Risk

K020964 is an FDA 510(k) clearance for the NEICH NM ADVANCE CATHETER SHEATH INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Neich Medical(Shenzhen)Company, Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 11, 2002 after a review of 200 days - an extended review cycle.

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: 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 Neich Medical(Shenzhen)Company, Ltd. devices

FDA 510(k) Submission Details - K020964

510(k) Number K020964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2002
Decision Date October 11, 2002
Days to Decision 200 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
75d slower than avg
Panel avg: 125d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

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 409
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K020964.
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