Eupalamus Deflectable Stylet, Model 01545

FDA 510(k) K002534 · Eupalamus, LLC

Substantially Equivalent

510(k) numberK002534

Submission

Device name
Eupalamus Deflectable Stylet, Model 01545
Applicant
Eupalamus, LLC
Brentwood, CA, US
Received
August 16, 2000
Decision date
October 18, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DRB – Stylet, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1380
Specialty
Cardiovascular

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K170298Liberator Beacon Tip Locking StyletDRB · Traditional Cook Incorporated10/18/2017SE
K142116LLD EzDRB · Special Spectranetics, Inc.08/12/2014SE
K090163Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078DRB · Traditional St Jude Medical04/01/2009SE
K080924Mond Rvot Stylet Models 4140, 4141, 4150, 4151DRB · Traditional St. Jude Medical, Cardiac Rhythm Management Divisi04/30/2008SE
K072864St. Jude Medical, CPS Duo Left Heart Lead Delivery SystemDRB · Traditional St. Jude Medical, Cardiac Rhythm Management Divisi03/13/2008SE
K053019Acuity Steerable Stylet AccessoryDRB · Traditional Guidant Corporation03/03/2006SE
K052965Easytrak 2 Stylet, Models 4826, 4829, 4832.DRB · Traditional Guidant Corporation02/13/2006SE

Questions and answers

When was Eupalamus Deflectable Stylet, Model 01545 cleared by the FDA?

Eupalamus Deflectable Stylet, Model 01545 (K002534) received a 510(k) decision of Substantially Equivalent on October 18, 2000, 63 days after the submission was received.

What is the product code of K002534?

The FDA product code is DRB – Stylet, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1380.