Cleared Traditional

SENDERO MAX Delivery Catheter (K242644) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242644 · Okami Medical, Inc. · Cardiovascular device
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Dec 2024
Decision
108d
Days
Class 2
Risk

K242644 is an FDA 510(k) clearance for the SENDERO MAX Delivery Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Okami Medical, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on December 20, 2024 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Okami Medical, Inc. devices

Submission Details

510(k) Number K242644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2024
Decision Date December 20, 2024
Days to Decision 108 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
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 318
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K242644.
Ventrax™ Delivery System
K242873 · Merit Medical Systems, Inc. · Jan 2025
COREPASS Modular Microcatheter (FLEX)
K242588 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Jan 2025
MitraClip™ G5 Steerable Guide Catheter (SGC0801)
K243224 · Abbott Medical · Dec 2024
Shadow Catheter
K240885 · Simpson Interventions, Inc. · Dec 2024
SSPC NXT Delivery Catheter
K243180 · CenterPoint Systems, LLC · Dec 2024
CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)
K242276 · Vantis Vascular, Inc. · Sep 2024