510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912636Substantially Equivalent

Annulus Valvulotome

Cardio Source, Malibu CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912636 is the FDA 510(k) clearance record for ANNULUS VALVULOTOME, a class II device, cleared for Cardio Source on under FDA product code MGZ (Valvulotome). FDA records list 2 510(k) clearances for Cardio Source. As of , FDA records show no recalls naming K912636.

Clearance record

Decision date
Received
(126 days to decision)
Product code
MGZ Valvulotome
Regulation
21 CFR 870.4885
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardio Source 3649 Seahorn Dr., Malibu CA
510(k) summary
Statement
Third party review
No

Clearances, product code MGZ

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