Cleared Traditional

K063182 - ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX

K063182 is an FDA 510(k) clearance for ENPATH MEDICAL VIASEAL VALVED PEELABLE ..., manufactured by Enpath Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K063182 · Enpath Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
63d
Days
Class 2
Risk

K063182 is an FDA 510(k) clearance for the ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Enpath Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 21, 2006 after a review of 63 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 Enpath Medical, Inc. devices

FDA 510(k) Submission Details - K063182

510(k) Number K063182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2006
Decision Date December 21, 2006
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
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 506
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K063182.
INTRAVASCULAR INTRODUCER SYSTEM
K063658 · Applied Medical Resources Corp. · Sep 2007
ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984
K070417 · St Jude Medical · Jun 2007
STRADA CAROTID GUIDING SHEATH
K070166 · St Jude Medical · Apr 2007
MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
K062446 · Terumo Medical Corp. · Oct 2006
MODIFICATION TO GLIDESHEATH
K062858 · Terumo Medical Corp. · Oct 2006
FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER
K061015 · St Jude Medical · Aug 2006