Cleared Traditional

K242644 - SENDERO MAX Delivery Catheter

K242644 is an FDA 510(k) clearance for SENDERO MAX Delivery Catheter, manufactured by Okami Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 108-day FDA review.

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

FDA 510(k) Submission Details - K242644

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.

DQY Device Classification - Class 2, Special Controls

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 621
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