510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN140009Unknown

Amigo Remote Catheter System

Catheter Robotics, Inc., Mt. Olive NJ / Direct, Unknown
FDA source (opens on fda.gov)

DEN140009 is the FDA 510(k) clearance record for AMIGO REMOTE CATHETER SYSTEM, a class II device, cleared for Catheter Robotics, Inc. on under FDA product code PJB (Catheter Remote Control System). FDA's definition for product code PJB reads: "A steerable cardiac ablation catheter remote control system is a device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation...". FDA records list 3 510(k) clearances for Catheter Robotics, Inc., from to . As of , FDA records show no recalls naming DEN140009.

Clearance record

Decision date
Received
(303 days to decision)
Product code
PJB Catheter Remote Control System
Regulation
21 CFR 870.5700
Device class
Class II
Review panel
Cardiovascular
Applicant
Catheter Robotics, Inc. 500 International Dr., Suite 255, Mt. Olive NJ
Third party review
No

Clearances, product code PJB

Trailing 12 months

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

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