Evalve Steerable Guide Catheter

FDA 510(k) K093866 · Evalve, Inc.

Substantially Equivalent

510(k) numberK093866

Submission

Device name
Evalve Steerable Guide Catheter
Applicant
Evalve, Inc.
Menlo Park, CA, US
Received
December 17, 2009
Decision date
January 13, 2010
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DRA – Catheter, Steerable
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1280
Specialty
Cardiovascular

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K192422Steerable Introducer 12FDRA · Traditional Freudenberg Medical, LLC10/04/2019SE

More from Freudenberg Medical, LLC

510(k)DeviceDecision
K100789Modificaton to: Steerable Guide Catheter, Model SGC01STDRA · Special 04/21/2010SE
K091596Evalve Steerable Guide Catheter, Model SGC01STDRA · Special 07/02/2009SE
K083793Steerable Guide CatheterDRA · Traditional 04/27/2009SE

Questions and answers

When was Evalve Steerable Guide Catheter cleared by the FDA?

Evalve Steerable Guide Catheter (K093866) received a 510(k) decision of Substantially Equivalent on January 13, 2010, 27 days after the submission was received.

What is the product code of K093866?

The FDA product code is DRA – Catheter, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1280.