Cleared Special

K060519 - INTRODUCER ASSEMBLY WITH ROTATOR LOCK

K060519 is the FDA 510(k) clearance for INTRODUCER ASSEMBLY WITH ROTATOR LOCK by Teleflex Medical. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Special 510(k) pathway after a 67-day FDA review.

K060519 · Teleflex Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
67d
Days
Class 2
Risk

K060519 is an FDA 510(k) clearance for the INTRODUCER ASSEMBLY WITH ROTATOR LOCK. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Teleflex Medical (Bannockburn, US). The FDA issued a Cleared decision on May 5, 2006 after a review of 67 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Teleflex Medical devices

Submission Details

510(k) Number K060519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2006
Decision Date May 05, 2006
Days to Decision 67 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
58d faster than avg
Panel avg: 125d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 391
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K060519.
MEDCOMP VASCU-SHEATH II
K053092 · Medcomp · Aug 2006
AGILIS NXT STEERABLE INTRODUCER
K061363 · St Jude Medical · Jul 2006
CAROTID ACCESS KIT
K060666 · Terumo Medical Corp. · Jun 2006
SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
K052644 · St Jude Medical · Dec 2005
VYGON MICRO-ACCESS SAFETY INTRODUCER KIT
K051248 · Vygon Corp. · Oct 2005
DESTINATION CAROTID GUIDING SHEATH
K052185 · Terumo Medical Corp. · Sep 2005