Cleared Traditional

K990705 - MEDAMICUS COAXIAL INTRODUCER KIT

K990705 is an FDA 510(k) clearance for MEDAMICUS COAXIAL INTRODUCER KIT, manufactured by Medamicus, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K990705 · Medamicus, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 1999
Decision
116d
Days
Class 2
Risk

K990705 is an FDA 510(k) clearance for the MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATO.... Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Medamicus, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 28, 1999 after a review of 116 days - within the typical 510(k) review window.

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 Medamicus, Inc. devices

FDA 510(k) Submission Details - K990705

510(k) Number K990705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1999
Decision Date June 28, 1999
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 125d · This submission: 116d
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 410
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K990705.
IN-LINE HEMOSTASIS VALVE
K990975 · Merit Medical Systems, Inc. · Mar 2000
INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE
K994252 · Boston Scientific Corp · Jan 2000
INTRODUCER SHEATH, VESSEL DILATOR
K992309 · Boston Scientific Corp · Oct 1999
PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)
K984260 · Terumo Medical Corp. · Jan 1999
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K984500 · Cordis Corp. · Dec 1998
MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K983023 · Cordis Corp. · Oct 1998