Drakon and Sequre Microcatheters

FDA 510(k) K202797 · Accurate Medical Therapeutics, Ltd.

Substantially Equivalent

510(k) numberK202797

Submission

Device name
Drakon and Sequre Microcatheters
Applicant
Accurate Medical Therapeutics, Ltd.
Rehovot, IL
Received
September 23, 2020
Decision date
October 23, 2020
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQO – Catheter, Intravascular, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1200
Specialty
Cardiovascular

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K250751DualView CatheterDQO · Traditional Terumo Corporation07/17/2025SE
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K242420pNOVUS 21 MicrocatheterDQO · Traditional Phenox, Ltd.11/12/2024SE
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K233975Zoom 6F Insert CathetersDQO · Traditional Imperative Care, Inc.04/02/2024SE
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K232573INFINITI™ Ambi Angiographic CatheterDQO · Traditional Cordis US Corp11/21/2023SE

More from Cordis US Corp

510(k)DeviceDecision
K231293Drakon™ and Sequre® MicrocathetersDQO · Special 06/01/2023SE
K203487Drakon and Sequre MicrocathetersDQO · Special 12/11/2020SE
K173430SeQure® NF and SeQure® MicrocathetersDQO · Traditional 01/26/2018SE

Questions and answers

When was Drakon and Sequre Microcatheters cleared by the FDA?

Drakon and Sequre Microcatheters (K202797) received a 510(k) decision of Substantially Equivalent on October 23, 2020, 30 days after the submission was received.

What is the product code of K202797?

The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.