Cleared Traditional

K163314 - Guidezilla II Guide Extension Catheter

Also marketed or referenced as:
Guidezilla II LONG Guide Extension Catheter

K163314 is an FDA 510(k) clearance for Guidezilla II Guide Extension Catheter, manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K163314 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
120d
Days
Class 2
Risk

K163314 is an FDA 510(k) clearance for the Guidezilla II Guide Extension Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on March 23, 2017 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Boston Scientific Corporation devices

FDA 510(k) Submission Details - K163314

510(k) Number K163314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2016
Decision Date March 23, 2017
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 783
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K163314.
Venture 038 catheter
K171335 · Vascular Solutions, Inc. · Jun 2017
Reverse 021 Micro Catheter, Reverse 027 Micro Catheter
K171268 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · May 2017
MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter
K163233 · Mivi Neuroscience, Inc. · Apr 2017
CenterCross Ultra LV Catheter
K170403 · Roxwood Medical, Inc. · Mar 2017
VIA 17 Microcatheter
K162565 · Sequent Medical, Inc. · Feb 2017
TrapLiner catheter
K161901 · Vascular Solutions, Inc. · Feb 2017