510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K010838Substantially Equivalent

Fox Pta Catheter, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 X 40 Mm, Models A14003, A14004, A14005, A14006, A14007, A14008

Jomed AG, Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010838 is the FDA 510(k) clearance record for FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008, a class II device, cleared for Jomed AG on under FDA product code DQY (Catheter, Percutaneous). FDA records list 3 510(k) clearances for Jomed AG, from to . As of , FDA records show no recalls naming K010838.

Clearance record

Decision date
Received
(93 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Jomed AG 1700 Rockville Pike,Suite# 400, Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code DQY

Trailing 12 months
13 clearances under product code DQY in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20261
April 20262
May 20260
June 20262
July 20263
August 20262
September 20261
October 20260