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FDA 510(k)

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C

K-Number: K161733 · 2017-03-08

ApplicantSorin Group Italia S.R.L.
Decision Date2017-03-08
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2017-03-08 under 510(k) number K161733. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C?

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C is a medical device that received FDA 510(k) clearance on 2017-03-08. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K161733.

When did INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C receive FDA 510(k) clearance?

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C received FDA 510(k) clearance on 2017-03-08, under 510(k) number K161733.

Who is the listed applicant for INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C?

The FDA product code for INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C is DTN.

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Related Devices (Code: DTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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