Evalve Steerable Guide Catheter, Model SGC01ST

Q: What is the product code of K091596?

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

FDA 510(k) K091596 · Evalve, Inc.

Substantially Equivalent

510(k) numberK091596

Submission

Device name: Evalve Steerable Guide Catheter, Model SGC01ST
Applicant: Evalve, Inc.
Menlo Park, CA, US
Received: June 2, 2009
Decision date: July 2, 2009
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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K221397	MitraClip G4 Steerable Guide CatheterDRA · Special	Abbott Medical	09/28/2022SE
K221044	AcQGuide® VUE Steerable SheathDRA · Traditional	Acutus Medical, Inc.	05/05/2022SE
K211100	AcQGuide MAX Steerable SheathDRA · Traditional	Acutus Medical, Inc.	05/14/2021SE
K202620	FlexCath Advance Steerable Sheath and DilatorDRA · Traditional	Medtronic Cryocath, LP	11/13/2020SE
K192422	Steerable Introducer 12FDRA · Traditional	Freudenberg Medical, LLC	10/04/2019SE

More from Freudenberg Medical, LLC

510(k)	Device	Decision
K100789	Modificaton to: Steerable Guide Catheter, Model SGC01STDRA · Special	04/21/2010SE
K093866	Evalve Steerable Guide CatheterDRA · Special	01/13/2010SE
K083793	Steerable Guide CatheterDRA · Traditional	04/27/2009SE

Questions and answers

When was Evalve Steerable Guide Catheter, Model SGC01ST cleared by the FDA?

Evalve Steerable Guide Catheter, Model SGC01ST (K091596) received a 510(k) decision of Substantially Equivalent on July 2, 2009, 30 days after the submission was received.

What is the product code of K091596?

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