Cleared Traditional

K121168 - APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH

K121168 is an FDA 510(k) clearance for APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE ..., manufactured by Aptus Endosystems, Inc.. The device is a Class 2 Cardiovascular device with product code OTD cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K121168 · Aptus Endosystems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
113d
Days
Class 2
Risk

K121168 is an FDA 510(k) clearance for the APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH. Classified as Endovascular Suturing System (product code OTD), Class II - Special Controls.

Submitted by Aptus Endosystems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 8, 2012 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3460 - 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 - K121168

510(k) Number K121168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2012
Decision Date August 08, 2012
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OTD Device Classification - Class 2, Special Controls

Product Code OTD Endovascular Suturing System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3460
Definition Provides Fixation And Sealing Between And Endovascular Graft And The Native Artery.
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 - OTD Endovascular Suturing System

Devices cleared under the same product code (OTD) and FDA review panel - the closest regulatory comparables to K121168.
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K121168 · APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
Download PDF FDA Summary Aptus Endosystems, In…