Cleared Special

K061015 - FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER

K061015 is an FDA 510(k) clearance for FAST-CATH HEMOSTASIS INTRODUCER AND TRA..., manufactured by St Jude Medical. The device is a Class 2 Cardiovascular device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K061015

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.

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 706
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K061015.
MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
K062446 · Terumo Medical Corp. · Oct 2006
MODIFICATION TO GLIDESHEATH
K062858 · Terumo Medical Corp. · Oct 2006
MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90
K062145 · Acumen Medical, Inc. · Aug 2006
MEDCOMP VASCU-SHEATH II
K053092 · Medcomp · Aug 2006
AGILIS NXT STEERABLE INTRODUCER
K061363 · St Jude Medical · Jul 2006
STARCLOSE INTRODUCER SET MODEL- 1002
K060902 · Abbott Vascular, Inc. · Jul 2006
K061015 · FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER
Download PDF FDA Summary St Jude Medical