Cleared Special

Morph DNA Steerable Introducer Sheath (K242169) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K242169 · Biocardia · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
30d
Days
Class 2
Risk

K242169 is an FDA 510(k) clearance for the Morph DNA Steerable Introducer Sheath. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Biocardia (Sunnyvale, US). The FDA issued a Cleared decision on August 23, 2024 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biocardia devices

Submission Details

510(k) Number K242169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2024
Decision Date August 23, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 272
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K242169.
AuST Steerable Sheath
K242106 · CenterPoint Systems, LLC · Oct 2024
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K241230 · Togo Medikit Co., Ltd. · Sep 2024
SafeCross Vascular Introducer System (4001)
K240600 · East End Medical I, LLC · Sep 2024
Introducer Sheath Kits
K242248 · Beijing Demax Medical Technology Co.,Ltd · Aug 2024
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K240957 · Contract Medical International, GmbH · Aug 2024
Abiomed 14Fr Low Profile Introducer Kit
K241708 · Abiomed, Inc. · Aug 2024