510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980016Substantially Equivalent

Millennium Valve Introducer/rotator Handle

Genzyme Surgical Product (Genzyme Biosurgery), North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980016 is the FDA 510(k) clearance record for MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE, a class I device, cleared for Genzyme Surgical Product (Genzyme Biosurgery) on under FDA product code MOP (Rotator, Prosthetic Heart Valve). FDA records list 9 510(k) clearances for Genzyme Surgical Product (Genzyme Biosurgery), from to . As of , FDA records show no recalls naming K980016.

Clearance record

Decision date
Received
(217 days to decision)
Product code
MOP Rotator, Prosthetic Heart Valve
Regulation
21 CFR 870.3935
Device class
Class I
Review panel
Cardiovascular
Applicant
Genzyme Surgical Product (Genzyme Biosurgery) 49 Plain St., North Attleboro MA
510(k) summary
Summary
Third party review
No

Clearances, product code MOP

Trailing 12 months

FDA records hold no clearances under product code MOP in the trailing twelve months.

FDA records show no clearances under product code MOP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MOP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260