FDA 510(k)

RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26

K-Number: K093877 · 2010-07-01

Decision Date2010-07-01

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2010-07-01 under 510(k) number K093877. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26?

RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 is a medical device that received FDA 510(k) clearance on 2010-07-01. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K093877.

When did RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 receive FDA 510(k) clearance?

RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 received FDA 510(k) clearance on 2010-07-01, under 510(k) number K093877.

Who is the listed applicant for RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26?

The FDA product code for RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 is DYB.

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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.