Cleared Traditional

K960200 - INTROSTAT LEAD INTRODUCER

K960200 is an FDA 510(k) clearance for INTROSTAT LEAD INTRODUCER, manufactured by Msi, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K960200 · Msi, Inc. · Cardiovascular device
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Jul 1996
Decision
181d
Days
Class 2
Risk

K960200 is an FDA 510(k) clearance for the INTROSTAT LEAD INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Msi, Inc. (Tarpon Springs, US). The FDA issued a Cleared decision on July 2, 1996 after a review of 181 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 Msi, Inc. devices

FDA 510(k) Submission Details - K960200

510(k) Number K960200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1996
Decision Date July 02, 1996
Days to Decision 181 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 125d · This submission: 181d
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 535
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K960200.
PERCUTANEOUS INTRODUCER SET
K961466 · Thomas Medical Products, Inc. · Sep 1996
INPUT TUOHY-BORST LOCKING DEVICE
K960445 · C.R. Bard, Inc. · Aug 1996
SPREADABLE SHEATH INTRODUCER SET
K960625 · Neostar Medical Technologies, Inc. · Aug 1996
PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET
K961513 · Ep Medsystems · May 1996
INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F)
K961135 · C.R. Bard, Inc. · Apr 1996
BRAUN HEMOSTASIS INTRODUCERS
K960406 · B.Braun Medical, Inc. · Apr 1996