Cleared Traditional

K974745 - MANAN GWI GUIDE WIRE INTRODUCER

K974745 is an FDA 510(k) clearance for MANAN GWI GUIDE WIRE INTRODUCER, manufactured by Medical Device Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K974745 · Medical Device Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Apr 1998
Decision
108d
Days
Class 2
Risk

K974745 is an FDA 510(k) clearance for the MANAN GWI GUIDE WIRE INTRODUCER. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Medical Device Technologies, Inc. (Gainsville, US). The FDA issued a Cleared decision on April 6, 1998 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - 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 Medical Device Technologies, Inc. devices

FDA 510(k) Submission Details - K974745

510(k) Number K974745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1997
Decision Date April 06, 1998
Days to Decision 108 days
Submission Type Traditional
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
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRC Device Classification - Class 2, Special Controls

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
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 - DRC Trocar

All 41
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K974745.
TRANSSEPTAL NEEDLE/TROCAR
K011727 · Thomas Medical Products, Inc. · May 2002
MANAN POTTS-COURNAND NEEDLE
K974742 · Medical Device Technologies, Inc. · Apr 1998
MANAN
K974743 · Medical Device Technologies, Inc. · Apr 1998
HEARTPORT THORACIC TROCAR
K964302 · Heartport, Inc. · May 1997
HEARTPORT NEEDLE TROCAR
K965051 · Heartport, Inc. · Mar 1997
GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE
K951448 · Global Medical Products, Ltd. · Mar 1996