Cleared Special

K002365 - DATASCOPE REINFORCED PERCUTANEOUS CATHE...

K002365 is the FDA 510(k) clearance for DATASCOPE REINFORCED PERCUTANEOUS CATHE... by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Special 510(k) pathway after a 22-day FDA review.

K002365 · Datascope Corp. · Cardiovascular device
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Aug 2000
Decision
22d
Days
Class 2
Risk

K002365 is an FDA 510(k) clearance for the DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Datascope Corp. (Fairfield, US). The FDA issued a Cleared decision on August 25, 2000 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Datascope Corp. devices

Submission Details

510(k) Number K002365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2000
Decision Date August 25, 2000
Days to Decision 22 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 378
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K002365.
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ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509
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PINNACLE R/O II OR RADIFOCUS INTRODUCER II
K003424 · Terumo Medical Corp. · Nov 2000
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K001135 · Cordis Corp. · Jul 2000
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K994334 · Daig Corp. · May 2000
PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
K001139 · Biosense Webster, Inc. · May 2000