Cleared Traditional

K221655 - Multiflex Steerable Sheath

K221655 is an FDA 510(k) clearance for Multiflex Steerable Sheath, manufactured by Vizaramed, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K221655 · Vizaramed, Inc. · Cardiovascular device
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Nov 2022
Decision
160d
Days
Class 2
Risk

K221655 is an FDA 510(k) clearance for the Multiflex Steerable Sheath. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Vizaramed, Inc. (San Jose, US). The FDA issued a Cleared decision on November 14, 2022 after a review of 160 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Vizaramed, Inc. devices

FDA 510(k) Submission Details - K221655

510(k) Number K221655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2022
Decision Date November 14, 2022
Days to Decision 160 days
Submission Type Traditional
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
35d slower than avg
Panel avg: 125d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 432
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K221655.
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K230051 · Boston Scientific Corporation · Feb 2023
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K223872 · Merit Medical Systems, Inc. · Jan 2023
Abiomed 14Fr Low Profile Introducer Set
K222113 · Abiomed, Inc. · Oct 2022
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K221914 · Contract Medical International, GmbH · Jul 2022
Epicardial Access System
K213582 · Baylis Medical Company, Inc. · Jun 2022