Cleared Special

K221397 - MitraClip G4 Steerable Guide Catheter

K221397 is an FDA 510(k) clearance for MitraClip G4 Steerable Guide Catheter, manufactured by Abbott Medical. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Special 510(k) pathway after a 138-day FDA review.

K221397 · Abbott Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
138d
Days
Class 2
Risk

K221397 is an FDA 510(k) clearance for the MitraClip G4 Steerable Guide Catheter. Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Abbott Medical (St.Paul, US). The FDA issued a Cleared decision on September 28, 2022 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1280 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K221397

510(k) Number K221397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 125d · This submission: 138d
Pathway characteristics
Modification to existing cleared device.

DRA Device Classification - Class 2, Special Controls

Product Code DRA Catheter, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1280
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRA Catheter, Steerable

All 41
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K221397.
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
FlexCath Advance Steerable Sheath and Dilator
K202620 · Medtronic Cryocath, LP · Nov 2020
K221397 · MitraClip G4 Steerable Guide Catheter
Download PDF FDA Summary Abbott Medical