Cleared Traditional

K171431 - HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm (FDA 510(k) Clearance)

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

K171431 · Biostable Science & Engineering, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
87d
Days
Class 2
Risk

K171431 is an FDA 510(k) clearance for the HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Devi.... Classified as Aortic Annuloplasty Ring (product code PST), Class II - Special Controls.

Submitted by Biostable Science & Engineering, Inc. (Austin, US). The FDA issued a Cleared decision on August 10, 2017 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3800 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biostable Science & Engineering, Inc. devices

Submission Details

510(k) Number K171431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2017
Decision Date August 10, 2017
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PST Aortic Annuloplasty Ring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3800
Definition To Correct Annular Dilatation And/or Maintain Annular Geometry Of The Aortic Valve.
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.