Cleared Special

MODIFICATION TO GLIDESHEATH (K062858) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K062858 · Terumo Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
25d
Days
Class 2
Risk

K062858 is an FDA 510(k) clearance for the MODIFICATION TO GLIDESHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on October 20, 2006 after a review of 25 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 Terumo Medical Corp. devices

Submission Details

510(k) Number K062858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2006
Decision Date October 20, 2006
Days to Decision 25 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
100d faster than avg
Panel avg: 125d · This submission: 25d
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 284
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K062858.
CONVOY ADVANCED DELIVERY SHEATH
K072719 · Boston Scientific Corp · Mar 2008
DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K080415 · Terumo Medical Corp. · Mar 2008
MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
K062446 · Terumo Medical Corp. · Oct 2006
CAROTID ACCESS KIT
K060666 · Terumo Medical Corp. · Jun 2006
DESTINATION CAROTID GUIDING SHEATH
K052185 · Terumo Medical Corp. · Sep 2005
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K051601 · Terumo Medical Corp. · Aug 2005