Cleared Traditional

K091367 - GDS-DCS

K091367 is an FDA 510(k) clearance for GDS-DCS, manufactured by Guided Delivery Systems. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K091367 · Guided Delivery Systems · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
181d
Days
Class 2
Risk

K091367 is an FDA 510(k) clearance for the GDS-DCS. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Guided Delivery Systems (Santa Clara, US). The FDA issued a Cleared decision on November 5, 2009 after a review of 181 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K091367

510(k) Number K091367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2009
Decision Date November 05, 2009
Days to Decision 181 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
56d slower than avg
Panel avg: 125d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 686
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K091367.
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K093130 · St Jude Medical · Nov 2009
PTFE PEELABLE INTRODUCER
K093023 · Great Batch Medical · Oct 2009
SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
K092014 · Onset Medical Corporation · Oct 2009
K091367 · GDS-DCS
Download PDF FDA Summary Guided Delivery Syste…