Cleared Special

K061015 - FAST-CATH HEMOSTASIS INTRODUCER AND TRA...

K061015 is the FDA 510(k) clearance for FAST-CATH HEMOSTASIS INTRODUCER AND TRA... by St Jude Medical. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Special 510(k) pathway after a 112-day FDA review.

K061015 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
112d
Days
Class 2
Risk

K061015 is an FDA 510(k) clearance for the FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by St Jude Medical (Minnetonka, US). The FDA issued a Cleared decision on August 3, 2006 after a review of 112 days - within the typical 510(k) review window.

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 St Jude Medical devices

Submission Details

510(k) Number K061015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2006
Decision Date August 03, 2006
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
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 396
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K061015.
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
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