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FDA 510(k)

INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER

K-Number: K864895 · 1987-02-19

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1987-02-19
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1987-02-19 under 510(k) number K864895. 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 INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER?

INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER is a medical device that received FDA 510(k) clearance on 1987-02-19. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K864895.

When did INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER receive FDA 510(k) clearance?

INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER received FDA 510(k) clearance on 1987-02-19, under 510(k) number K864895.

Who is the listed applicant for INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER?

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

What is the FDA product code for INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER?

The FDA product code for INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER is DTN.

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Related Devices (Code: DTN)

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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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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