Reprocessed Deflectable Electrophysiology Diagnostic Catheters

FDA 510(k) K051220 · Sterilmed, Inc.

Substantially Equivalent

510(k) numberK051220

Submission

Device name
Reprocessed Deflectable Electrophysiology Diagnostic Catheters
Applicant
Sterilmed, Inc.
Maple Grove, MN, US
Received
May 12, 2005
Decision date
June 14, 2005
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

510(k)DeviceApplicantDecision
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

510(k)DeviceDecision
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
K182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ · Traditional 04/15/2019SE
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
K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterNLH · Traditional 06/23/2016SE
K152090Reprocessed Steerable IntroducerPNE · Traditional 03/23/2016SE
K152134Reprocessed Vessel SealerNUJ · Traditional 01/15/2016SE

Questions and answers

When was Reprocessed Deflectable Electrophysiology Diagnostic Catheters cleared by the FDA?

Reprocessed Deflectable Electrophysiology Diagnostic Catheters (K051220) received a 510(k) decision of Substantially Equivalent on June 14, 2005, 33 days after the submission was received.

What is the product code of K051220?

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