St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter

Q: What is the product code of K150631?

The FDA product code is DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording, a Class II (moderate risk) device regulated under 21 CFR 870.1220.

FDA 510(k) K150631 · St Jude Medical

Substantially Equivalent

510(k) numberK150631

Submission

Device name: St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter
Applicant: St Jude Medical
Minnetonka, MN, US
Received: March 11, 2015
Decision date: April 1, 2015
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1220
Specialty: Cardiovascular

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K233397	Cosine-10TM Diagnostic CatheterDRF · Traditional	Medtronic, Inc.	12/02/2023SE
K233207	Polaris X Unidirectional Steerable Diagnostic CatheterDRF · Special	Boston Scientific Corporation	10/27/2023SE
K232651	BLAZER Dx-20 Bidirectional Steerable Diagnostic CatheterDRF · Special	Boston Scientific Corporation	09/29/2023SE
K230503	Polaris X Catheter Cable, Blazer Dx-20 Catheter CableDRF · Traditional	Boston Scientific	04/25/2023SE
K210313	EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping CatheterDRF · Traditional	Shanghai Microport EP Medtech Co., Ltd.	12/30/2022SE

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Questions and answers

When was St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter cleared by the FDA?

St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter (K150631) received a 510(k) decision of Substantially Equivalent on April 1, 2015, 21 days after the submission was received.

What is the product code of K150631?

The FDA product code is DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording, a Class II (moderate risk) device regulated under 21 CFR 870.1220.