FDA 510(k)

SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM

K-Number: K021830 · 2002-07-02

Decision Date2002-07-02

Product CodeDTR

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Cardiovascular, Inc.. It received FDA 510(k) clearance on 2002-07-02 under 510(k) number K021830. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM?

SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM is a medical device that received FDA 510(k) clearance on 2002-07-02. The listed applicant is Cobe Cardiovascular, Inc.. The 510(k) number is K021830.

When did SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM receive FDA 510(k) clearance?

SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM received FDA 510(k) clearance on 2002-07-02, under 510(k) number K021830.

Who is the listed applicant for SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM?

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

What is the FDA product code for SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM?

The FDA product code for SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM is DTR.

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Other records listing Cobe Cardiovascular, Inc. as applicant

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Related Devices (Code: DTR)

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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.