Reprocessed 2515 Nav Variable Electrophysiology Catheter

FDA 510(k) K112292 · Stryker Sustainability Solutions

Substantially Equivalent

510(k) numberK112292

Submission

Device name
Reprocessed 2515 Nav Variable Electrophysiology Catheter
Applicant
Stryker Sustainability Solutions
Tempe, AZ, US
Received
August 10, 2011
Decision date
October 21, 2011
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
K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional 06/18/2026SE
K250898Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears…NLQ · Traditional 08/14/2025SE
K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…NLF · Traditional 10/22/2024SE
K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…NLQ · Special 07/03/2024SE
K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…NLQ · Traditional 02/20/2024SE
K231621Reprocessed ViewFlex Xtra ICE Catheter (D087031)OWQ · Special 07/25/2023SE
K230255Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019GEI · Special 03/28/2023SE
K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ · Special 03/28/2023SE
K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…NLF · Traditional 12/04/2022SE
K220481Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)GEI · Traditional 05/25/2022SE

Questions and answers

When was Reprocessed 2515 Nav Variable Electrophysiology Catheter cleared by the FDA?

Reprocessed 2515 Nav Variable Electrophysiology Catheter (K112292) received a 510(k) decision of Substantially Equivalent on October 21, 2011, 72 days after the submission was received.

What is the product code of K112292?

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