Cleared Special

K063658 - INTRAVASCULAR INTRODUCER SYSTEM

K063658 is an FDA 510(k) clearance for INTRAVASCULAR INTRODUCER SYSTEM, manufactured by Applied Medical Resources Corp.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 278-day FDA review.

K063658 · Applied Medical Resources Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
278d
Days
Class 2
Risk

K063658 is an FDA 510(k) clearance for the INTRAVASCULAR INTRODUCER SYSTEM. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on September 12, 2007 after a review of 278 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Applied Medical Resources Corp. devices

FDA 510(k) Submission Details - K063658

510(k) Number K063658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2006
Decision Date September 12, 2007
Days to Decision 278 days
Submission Type Special
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
153d slower than avg
Panel avg: 125d · This submission: 278d
Pathway characteristics
Modification to existing cleared device.

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 438
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K063658.
CONVOY ADVANCED DELIVERY SHEATH
K072719 · Boston Scientific Corp · Mar 2008
DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K080415 · Terumo Medical Corp. · Mar 2008
INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S
K073100 · Oscor, Inc. · Nov 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