FDA 510(k)

SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR

K-Number: K092315 · 2009-08-12

Decision Date2009-08-12

Product CodeDTN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR 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 2009-08-12 under 510(k) number K092315. 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 SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR?

SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR is a medical device that received FDA 510(k) clearance on 2009-08-12. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K092315.

When did SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR receive FDA 510(k) clearance?

SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR received FDA 510(k) clearance on 2009-08-12, under 510(k) number K092315.

Who is the listed applicant for SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR?

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 SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR?

The FDA product code for SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR is DTN.

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Related Devices (Code: DTN)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.