Cleared Traditional

SENDERO Microcatheter (K231600) - FDA 510(k) Clearance

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

K231600 · Okami Medical, Inc. · Cardiovascular device
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Nov 2023
Decision
169d
Days
Class 2
Risk

K231600 is an FDA 510(k) clearance for the SENDERO Microcatheter. 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 November 17, 2023 after a review of 169 days - an extended review cycle.

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 K231600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2023
Decision Date November 17, 2023
Days to Decision 169 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 125d · This submission: 169d
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 319
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K231600.
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K233858 · Trisalus Life Sciences · Dec 2023
091 Balloon Guide Catheter
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Paragon 8F Balloon Guide Catheter
K232437 · Wallaby Medical · Oct 2023
Microcatheter
K232647 · Surmodics,Inc. · Sep 2023