510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180904Substantially Equivalent

Sniper Infusion Catheter with Balloon Occlusion

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

K180904 is the FDA 510(k) clearance record for Sniper Infusion Catheter with Balloon Occlusion, a class II device, cleared for Embolx, Inc. on under FDA product code MJN (Catheter, Intravascular Occluding, Temporary). FDA records list 3 510(k) clearances for Embolx, Inc., from to . As of , FDA records show no recalls naming K180904.

Clearance record

Decision date
Received
(63 days to decision)
Product code
MJN Catheter, Intravascular Occluding, Temporary
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Embolx, Inc. 530 Lakeside, Suite 200, Sunnyvale CA
510(k) summary
Summary PDF
Third party review
Yes

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