Cleared Traditional

K070749 - ESTECH PERCUTANEOUS INSERTION DILATOR KIT

K070749 is an FDA 510(k) clearance for ESTECH PERCUTANEOUS INSERTION DILATOR KIT, manufactured by Coombs Medical Device Consulting. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K070749 · Coombs Medical Device Consulting · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
219d
Days
Class 2
Risk

K070749 is an FDA 510(k) clearance for the ESTECH PERCUTANEOUS INSERTION DILATOR KIT. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Coombs Medical Device Consulting (Alameda, US). The FDA issued a Cleared decision on October 24, 2007 after a review of 219 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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.

FDA 510(k) Submission Details - K070749

510(k) Number K070749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2007
Decision Date October 24, 2007
Days to Decision 219 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
94d slower than avg
Panel avg: 125d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRE Device Classification - Class 2, Special Controls

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 102
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K070749.
HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
K082075 · Hansen Medical, Inc. · Aug 2008
PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
K073035 · Merit Medical Systems, Inc. · Nov 2007
GALTSTICK INTRODUCER SYSTEM
K071330 · Galt Medical Corp. · Oct 2007
PRELUDE SHEATH INTRODUCER
K070159 · Merit Medical Systems, Inc. · Jun 2007
STARCLOSE HEX-HUB DILATOR
K062554 · Abbott Vascular, Inc. · Feb 2007
EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0
K061000 · Cook Vascular, Inc. · May 2006
K070749 · ESTECH PERCUTANEOUS INSERTION DILATOR KIT
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