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FDA 510(k)

SC-2500F CARDIOTOMY RESERVIOR

K-Number: K813268 · 1982-05-18

ApplicantScimed Life Systems, Inc.
Decision Date1982-05-18
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SC-2500F CARDIOTOMY RESERVIOR is the device name listed in this FDA 510(k) record. The listed applicant is Scimed Life Systems, Inc.. It received FDA 510(k) clearance on 1982-05-18 under 510(k) number K813268. 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 SC-2500F CARDIOTOMY RESERVIOR?

SC-2500F CARDIOTOMY RESERVIOR is a medical device that received FDA 510(k) clearance on 1982-05-18. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K813268.

When did SC-2500F CARDIOTOMY RESERVIOR receive FDA 510(k) clearance?

SC-2500F CARDIOTOMY RESERVIOR received FDA 510(k) clearance on 1982-05-18, under 510(k) number K813268.

Who is the listed applicant for SC-2500F CARDIOTOMY RESERVIOR?

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

What is the FDA product code for SC-2500F CARDIOTOMY RESERVIOR?

The FDA product code for SC-2500F CARDIOTOMY RESERVIOR is DTN.

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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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