Cleared Traditional

K980016 - MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE

K980016 is an FDA 510(k) clearance for MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE, manufactured by Genzyme Surgical Product (Genzyme Biosurgery). The device is a Class 1 Cardiovascular device with product code MOP cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K980016 · Genzyme Surgical Product (Genzyme Biosurgery) · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
217d
Days
Class 1
Risk

K980016 is an FDA 510(k) clearance for the MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE. Classified as Rotator, Prosthetic Heart Valve (product code MOP), Class I - General Controls.

Submitted by Genzyme Surgical Product (Genzyme Biosurgery) (North Attleboro, US). The FDA issued a Cleared decision on August 7, 1998 after a review of 217 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3935 - 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 Genzyme Surgical Product (Genzyme Biosurgery) devices

FDA 510(k) Submission Details - K980016

510(k) Number K980016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1998
Decision Date August 07, 1998
Days to Decision 217 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
92d slower than avg
Panel avg: 125d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

MOP Device Classification - Class 1, General Controls

Product Code MOP Rotator, Prosthetic Heart Valve
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.3935
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.