510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122488Substantially Equivalent

Amigo Remote Catheter System & Accessories

Catheter Robotics, Inc., Mount Olive NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122488 is the FDA 510(k) clearance record for AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES, a class II device, cleared for Catheter Robotics, Inc. on under FDA product code DXX (System, Catheter Control, Steerable). FDA records list 3 510(k) clearances for Catheter Robotics, Inc., from to . As of , FDA records show no recalls naming K122488.

Clearance record

Decision date
Received
(97 days to decision)
Product code
DXX System, Catheter Control, Steerable
Regulation
21 CFR 870.1290
Device class
Class II
Review panel
Cardiovascular
Applicant
Catheter Robotics, Inc. 500 International Dr., Mount Olive NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXX

Trailing 12 months
2 clearances under product code DXX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260