Cleared Traditional

K163608 - HAART 300 Aortic Annuloplasty Device 19mm

K163608 is an FDA 510(k) clearance for HAART 300 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 90-day FDA review.

K163608 · Biostable Science & Engineering, Inc. · Cardiovascular device
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Mar 2017
Decision
90d
Days
Class 2
Risk

K163608 is an FDA 510(k) clearance for the HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 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 March 21, 2017 after a review of 90 days - within the typical 510(k) review window.

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: 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 Biostable Science & Engineering, Inc. devices

FDA 510(k) Submission Details - K163608

510(k) Number K163608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2016
Decision Date March 21, 2017
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.