510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K143613Substantially Equivalent

PaxWire Occlusion Balloon System

Accessclosure, Inc., Santa Clara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143613 is the FDA 510(k) clearance record for PaxWire Occlusion Balloon System, a class II device, cleared for Accessclosure, Inc. on under FDA product code MJN (Catheter, Intravascular Occluding, Temporary). FDA records list one 510(k) clearance for Accessclosure, Inc. As of , FDA records show one recall naming K143613.

Clearance record

Decision date
Received
(238 days to decision)
Product code
MJN Catheter, Intravascular Occluding, Temporary
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Accessclosure, Inc. 5452 Besty Ross Dr., Santa Clara 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 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