Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter

FDA 510(k) K153006 · Sterilmed, Inc.

Substantially Equivalent

510(k) numberK153006

Submission

Device name
Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter
Applicant
Sterilmed, Inc.
Plymouth, MN, US
Received
October 14, 2015
Decision date
June 23, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NLH – Catheter, Recording, Electrode, Reprocessed
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1220
Specialty
Cardiovascular

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other 510(k)s with product code NLH

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K252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable…NLH · Traditional Surgical Instrument Service and Savings, Inc.11/26/2025SE
K250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable…NLH · Traditional Surgical Instrument Service and Savings, Inc.07/11/2025SE
K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterNLH · Traditional Surgical Instrument Service and Savings, Inc.11/29/2024SE
K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…NLH · Traditional Surgical Instrument Service and Savings Inc.(Dba…11/15/2024SE
K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…NLH · Traditional Sterilmed, Inc.10/11/2024SE
K241156Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter…NLH · Traditional Surgical Instrument Service and Savings, Inc.09/14/2024SE
K240972Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)NLH · Traditional Surgical Instrument Service and Savings, Inc.06/07/2024SE
K233825Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterNLH · Traditional Innovative Health06/07/2024SE
K221067Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterNLH · Traditional Surgical Instrument Service and Savings, Inc.05/31/2023SE
K221854Reprocesses Umbilical CableNLH · Traditional Innovative Health, LLC08/06/2022SE

More from Innovative Health, LLC

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K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…OWQ · Traditional 06/29/2026SE
K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…NLH · Traditional 10/11/2024SE
K190478Reprocessed ViewFlex™ Xtra ICE CatheterOWQ · Traditional 11/14/2019SE
K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional 08/15/2019SE
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K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…OWQ · Traditional 11/21/2016SE
K161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed…NUJ · Traditional 09/20/2016SE
K152090Reprocessed Steerable IntroducerPNE · Traditional 03/23/2016SE
K152134Reprocessed Vessel SealerNUJ · Traditional 01/15/2016SE
K150357Reprocessed Electrophysiology Diagnostic CathetersNLH · Traditional 08/27/2015SE

Questions and answers

When was Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter cleared by the FDA?

Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter (K153006) received a 510(k) decision of Substantially Equivalent on June 23, 2016, 253 days after the submission was received.

What is the product code of K153006?

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