Cleared Special

PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (K081046) - FDA 510(k) Clearance

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

K081046 · Terumo Medical Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2008
Decision
37d
Days
Class 2
Risk

K081046 is an FDA 510(k) clearance for the PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH. 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 May 21, 2008 after a review of 37 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 K081046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2008
Decision Date May 21, 2008
Days to Decision 37 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
88d faster than avg
Panel avg: 125d · This submission: 37d
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 K081046.
GLIDESHEATH
K082644 · Terumo Medical Corp. · Sep 2008
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
K082356 · W.L. Gore & Associates, Inc. · Aug 2008
DESTINATION RENAL GUIDING SHEATH
K081045 · Terumo Medical Corp. · May 2008
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