# K980016: Millennium Valve Introducer/Rotator Handle

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Surgical Product (Genzyme Biosurgery)
- Decided: Aug 7, 1998 after 217 days
- Product code: MOP (Rotator, Prosthetic Heart Valve)
- Device class: 1
- Regulation: 21 CFR 870.3935
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930667 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960400: Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts), Snowden-Pencer (1996) Summary page 1.
- K951368: Carbomedics Exended Mitral Rotator, Carbomedics, Inc. (1995) Summary page 1.
- K962154: Carbomedics Handle, Carbomedics, Inc. (1996) Summary page 1.

## Indications for use
The Genzyme Surgical Products Millennium Valve Introducer/Rotator Handle is indicated for use during open and minimally invasive cardiac valve surgeries. This instrument is indicated for surgical introduction and rotation of a Sulzer Carbomedics Low Profile Mitral Valve Sizer and Rotator.

Source page: https://510kreport.com/device/K980016
Methodology: https://510kreport.com/methodology