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FDA 510(k)

PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F

K-Number: K926338 · 1994-07-26

ApplicantDeknatel, Inc.
Decision Date1994-07-26
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F is the device name listed in this FDA 510(k) record. The listed applicant is Deknatel, Inc.. It received FDA 510(k) clearance on 1994-07-26 under 510(k) number K926338. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F?

PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F is a medical device that received FDA 510(k) clearance on 1994-07-26. The listed applicant is Deknatel, Inc.. The 510(k) number is K926338.

When did PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F receive FDA 510(k) clearance?

PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F received FDA 510(k) clearance on 1994-07-26, under 510(k) number K926338.

Who is the listed applicant for PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F?

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

What is the FDA product code for PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F?

The FDA product code for PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F is CAC.

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Other records listing Deknatel, Inc. as applicant

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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Related Devices (Code: CAC)

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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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