Decision Date2011-10-21
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2011-10-21 under 510(k) number K112292. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER?
REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER is a medical device that received FDA 510(k) clearance on 2011-10-21. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K112292.
When did REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER receive FDA 510(k) clearance?
REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER received FDA 510(k) clearance on 2011-10-21, under 510(k) number K112292.
Who is the listed applicant for REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER?
The FDA 510(k) record lists Stryker Sustainability Solutions as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER?
The FDA product code for REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER is NLH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.