Cleared Traditional

K101399 - COAXIAL INTRODUCER SET

K101399 is an FDA 510(k) clearance for COAXIAL INTRODUCER SET, manufactured by Martech Medical Products. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K101399 · Martech Medical Products · Cardiovascular device
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Jun 2010
Decision
30d
Days
Class 2
Risk

K101399 is an FDA 510(k) clearance for the COAXIAL INTRODUCER SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Martech Medical Products (Harleysville, US). The FDA issued a Cleared decision on June 17, 2010 after a review of 30 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Martech Medical Products devices

FDA 510(k) Submission Details - K101399

510(k) Number K101399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2010
Decision Date June 17, 2010
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 487
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K101399.
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