Cleared Special

K202797 - Drakon and Sequre Microcatheters

K202797 is the FDA 510(k) clearance for Drakon and Sequre Microcatheters by Accurate Medical Therapeutics, Ltd.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Special 510(k) pathway after a 30-day FDA review.

K202797 · Accurate Medical Therapeutics, Ltd. · Cardiovascular device
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Oct 2020
Decision
30d
Days
Class 2
Risk

K202797 is an FDA 510(k) clearance for the Drakon and Sequre Microcatheters. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Accurate Medical Therapeutics, Ltd. (Rehovot, IL). The FDA issued a Cleared decision on October 23, 2020 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Accurate Medical Therapeutics, Ltd. devices

Submission Details

510(k) Number K202797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2020
Decision Date October 23, 2020
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 Peers - DQO Catheter, Intravascular, Diagnostic

All 291
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