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FDA 510(k)

SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M

K-Number: K961246 · 1997-02-14

ApplicantSt. Jude Medical, Inc.
Decision Date1997-02-14
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M 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 1997-02-14 under 510(k) number K961246. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M?

SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M is a medical device that received FDA 510(k) clearance on 1997-02-14. The listed applicant is St. Jude Medical, Inc.. The 510(k) number is K961246.

When did SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M receive FDA 510(k) clearance?

SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M received FDA 510(k) clearance on 1997-02-14, under 510(k) number K961246.

Who is the listed applicant for SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M?

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 SEGUIN ANNULOPLASTY RING MODEL SAR-M?

The FDA product code for SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M is KRH.

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Related Devices (Code: 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.

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