FDA 510(k)

DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40

K-Number: K961869 · 1996-08-12

Decision Date1996-08-12

Product CodeDTM

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedical, Inc.. It received FDA 510(k) clearance on 1996-08-12 under 510(k) number K961869. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40?

DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 is a medical device that received FDA 510(k) clearance on 1996-08-12. The listed applicant is Sorin Biomedical, Inc.. The 510(k) number is K961869.

When did DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 receive FDA 510(k) clearance?

DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 received FDA 510(k) clearance on 1996-08-12, under 510(k) number K961869.

Who is the listed applicant for DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40?

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

What is the FDA product code for DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40?

The FDA product code for DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 is DTM.

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Other records listing Sorin Biomedical, Inc. as applicant

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Related Devices (Code: DTM)

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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.