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REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER

K112292 Class II Traditional
Decision Date
2011-10-21
Sponsor / Applicant
Stryker Sustainability Solutions

Technical Specification

510(k) Submission ID K112292
Product Code NLH
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1220
Decision Date 2011-10-21
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER received FDA 510(k) clearance under submission number K112292, sponsored by Stryker Sustainability Solutions. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-10-21.

Classification & Regulation

This clearance is catalogued under FDA product code NLH and 21 CFR 870.1220, within the Cardiovascular review panel as a Class II device.