FDA 510(k)

SJM RIGID SADDLE RING MODEL RSAR-(SIZE)

K-Number: K042734 · 2004-12-17

Decision Date2004-12-17

Product CodeKRH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SJM RIGID SADDLE RING MODEL RSAR-(SIZE) is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Inc.. It received FDA 510(k) clearance on 2004-12-17 under 510(k) number K042734. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SJM RIGID SADDLE RING MODEL RSAR-(SIZE)?

SJM RIGID SADDLE RING MODEL RSAR-(SIZE) is a medical device that received FDA 510(k) clearance on 2004-12-17. The listed applicant is St. Jude Medical, Inc.. The 510(k) number is K042734.

When did SJM RIGID SADDLE RING MODEL RSAR-(SIZE) receive FDA 510(k) clearance?

SJM RIGID SADDLE RING MODEL RSAR-(SIZE) received FDA 510(k) clearance on 2004-12-17, under 510(k) number K042734.

Who is the listed applicant for SJM RIGID SADDLE RING MODEL RSAR-(SIZE)?

The FDA 510(k) record lists St. Jude Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SJM RIGID SADDLE RING MODEL RSAR-(SIZE)?

The FDA product code for SJM RIGID SADDLE RING MODEL RSAR-(SIZE) is KRH.

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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.