510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K964968Substantially Equivalent

Mr Extension Set (001)

University of Michigan, Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964968 is the FDA 510(k) clearance record for MR EXTENSION SET (001), a class II device, cleared for University of Michigan on under FDA product code FPA (Set, Administration, Intravascular). FDA records list 2 510(k) clearances for University of Michigan, from to . As of , FDA records show no recalls naming K964968.

Clearance record

Decision date
Received
(77 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
University of Michigan 1500 E. Medical Center Dr., Ann Arbor MI
510(k) summary
Statement
Third party review
No

Clearances, product code FPA

Trailing 12 months
5 clearances under product code FPA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260