Cleared Traditional

K231600 - SENDERO Microcatheter

K231600 is an FDA 510(k) clearance for SENDERO Microcatheter, 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 169-day FDA review.

K231600 · Okami Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K231600

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.

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 K231600.
WATCHMAN TruSteer Access System (M635TU90050)
K240018 · Boston Scientific Corporation · Feb 2024
Teleport XT Microcatheter
K231608 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Jan 2024
TriSalus TriGuideTM Guiding Catheter
K233858 · Trisalus Life Sciences · Dec 2023
091 Balloon Guide Catheter
K231629 · Eosolutions, Corp. · Oct 2023
Paragon 8F Balloon Guide Catheter
K232437 · Wallaby Medical · Oct 2023
Microcatheter
K232647 · Surmodics,Inc. · Sep 2023