510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K091458Substantially Equivalent

Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112, 104-4113, 104-4127,104-4132,104

Medtronic, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091458 is the FDA 510(k) clearance record for HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104, a class II device, cleared for Ev3 Neurovascular on under FDA product code MJN (Catheter, Intravascular Occluding, Temporary). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K091458.

Clearance record

Decision date
Received
(150 days to decision)
Product code
MJN Catheter, Intravascular Occluding, Temporary
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Ev3 Neurovascular 9775 Toledo Way, Irvine CA
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MJN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260