Cleared Traditional

PINNACLE PRECISION ACCESS SYSTEM (K111606) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K111606 · Terumo Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
116d
Days
Class 2
Risk

K111606 is an FDA 510(k) clearance for the PINNACLE PRECISION ACCESS SYSTEM. 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 3, 2011 after a review of 116 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Terumo Medical Corp. devices

Submission Details

510(k) Number K111606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2011
Decision Date October 03, 2011
Days to Decision 116 days
Submission Type Traditional
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
9d faster than avg
Panel avg: 125d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 281
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K111606.
EDWARDS PERCUTANEOUS SHEATH INTRODUCER
K121185 · Edwards Lifesciences, LLC · Aug 2012
PRELUDE 7F SHORT SHEATH INTRODUCER
K122190 · Merit Medical Systems, Inc. · Aug 2012
GORE DRYSEAL SHEATH
K120428 · W.L. Gore & Associates, Inc. · Apr 2012
GLIDESHEATH
K102008 · Terumo Medical Corp. · Jul 2010
RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26
K093877 · Edwards Lifesciences, LLC · Jul 2010
GORE DRYSEAL SHEATH
K093791 · W.L. Gore & Associates, Inc. · Mar 2010