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

K171431 is an FDA 510(k) clearance for HAART 200 Aortic Annuloplasty Device 19mm, manufactured by Biostable Science & Engineering, Inc.. The device is a Class 2 Cardiovascular device with product code PST cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K171431 · Biostable Science & Engineering, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K171431

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

PST Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice M. Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02071849 Completed Interventional Industry-sponsored

HAART 200 Aortic Valve Annuloplasty Trial

HAART 200 Aortic Valve Annuloplasty During Bicuspid Aortic Valve Reconstruction Trial

20
Patients (actual)
4
Sites
Treatment
Purpose
Open label
Masking
Condition studied Aortic Insufficiency
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Dominico Mazzitelli, MD
Sponsor Biostable Science & Engineering (industry)
Started 2013-09-01 → Primary completion 2015-04-01 → Completed 2016-08-01
Primary outcome
Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure.
Secondary outcome
Implant Procedure Success
View full study on ClinicalTrials.gov
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
Download PDF FDA Summary Biostable Science & E…