Cleared Special

MitraClip G4 Steerable Guide Catheter

K221397 · Abbott Medical · Cardiovascular
Sep 2022
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K221397 is an FDA 510(k) clearance for the MitraClip G4 Steerable Guide Catheter, a Catheter, Steerable (Class II — Special Controls, product code DRA), submitted by Abbott Medical (St.Paul, US). The FDA issued a Cleared decision on September 28, 2022, 138 days after receiving the submission on May 13, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1280.

Submission Details

510(k) Number K221397 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2022
Decision Date September 28, 2022
Days to Decision 138 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRA — Catheter, Steerable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1280

Similar Devices — DRA Catheter, Steerable

All 40
Globe Introducer (601-01001)
K250529 · Kardium, Inc. · Jun 2025
FARADRIVE? Steerable Sheath
K233248 · Boston Scientific Corporation · Dec 2023
FlexCath Contour? Steerable Sheath
K232321 · Medtronic, Inc. · Oct 2023
POLARSHEATH? Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP? Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP? EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE? Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE? Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE? 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE? CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE? Pressure Sensor
K223824 · Boston Scientific Corporation · Mar 2023
AcQGuide? VUE Steerable Sheath
K221044 · Acutus Medical, Inc. · May 2022
AcQGuide MAX Steerable Sheath
K211100 · Acutus Medical, Inc. · May 2021