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SwiftNINJA Steerable Microcatheter

by Merit Medical Systems, Inc.

510(k) K211525

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK211525 Date16 Jul 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KRA
Device Class
Class II
Regulation
21 CFR Part 870.1210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SwiftNINJA Steerable Microcatheter is a steerable/articulating distal tip microcatheter designed for vascular access. It features a steering dial mechanism at the proximal handle that allows the operator to manipulate the tip up to 180 degrees in opposing directions to select challenging vascular ostia without the use of a guidewire.

Supplied as a sterile, single-use device, it is intended for use in cardiovascular procedures. The device has received FDA 510(k) clearance (K211525) and is classified as a Class II device under regulation number 870.1210 with product code KRA. It is manufactured by Merit Medical Systems, Inc. and distributed from South Jordan, Utah, USA.

From the manufacturer

SwiftNINJA® Steerable Microcatheter VESSEL SELECTION WITHOUT A GUIDE WIRE SwiftNINJA, a straight tip catheter that articulates up to 180 degrees in opposing directions to rapidly select the most challenging vascular ostium. Speed, Control and Delivery at your fingertips.

Source: merit.com

The Merit SwiftNINJA® is a microcatheter with a steerable/articulating distal tip. Articulation is achieved via a steering dial at the proximal handle which allows the operator to manipulate the tip up to 180 degrees in opposing directions.

Source: cloud.merit.com

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SwiftNINJA Steerable Microcatheter used for?

    It is designed for vascular access in cardiovascular procedures, allowing operators to steer the distal tip up to 180 degrees in opposing directions via a proximal handle dial to select challenging vascular ostia without a guidewire.

  • Is the SwiftNINJA Steerable Microcatheter sterile and single-use?

    Yes, it is supplied as a sterile, single-use device, meaning it is intended for one patient procedure only and must be discarded after use to prevent cross-contamination and ensure patient safety.

  • What regulatory pathway was used for the SwiftNINJA Steerable Microcatheter?

    The device received FDA 510(k) clearance under submission K211525, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device under regulation 870.1210 with product code KRA.