510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K053440Substantially Equivalent

Amplatzer Sizing Balloon II

Abbott Medical, Plymouth MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053440 is the FDA 510(k) clearance record for AMPLATZER SIZING BALLOON II, a class II device, cleared for Aga Medical Corp. on under FDA product code MJN (Catheter, Intravascular Occluding, Temporary). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show 2 recalls naming K053440.

Clearance record

Decision date
Received
(21 days to decision)
Product code
MJN Catheter, Intravascular Occluding, Temporary
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Aga Medical Corp. 682 Mendelssohn Ave., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MJN

Trailing 12 months

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

FDA records show no clearances under product code MJN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MJN, 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