Cleared Traditional

K173430 - SeQure NF and SeQure Microcatheters

K173430 is the FDA 510(k) clearance for SeQure NF and SeQure Microcatheters by Accurate Medical Therapeutics, Ltd.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K173430 · Accurate Medical Therapeutics, Ltd. · Cardiovascular device
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Jan 2018
Decision
85d
Days
Class 2
Risk

K173430 is an FDA 510(k) clearance for the SeQure® NF and SeQure® Microcatheters. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Accurate Medical Therapeutics, Ltd. (Tel-Aviv, IL). The FDA issued a Cleared decision on January 26, 2018 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Accurate Medical Therapeutics, Ltd. devices

Submission Details

510(k) Number K173430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2017
Decision Date January 26, 2018
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 Consultant

Orly Maor
Orly Maor

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 291
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