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FDA 510(k)

INTERSEPT* VENOUS RESERVOIR BAG & HOLDER

K-Number: K803059 · 1980-12-22

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1980-12-22
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERSEPT* VENOUS RESERVOIR BAG & HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K803059. 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* VENOUS RESERVOIR BAG & HOLDER?

INTERSEPT* VENOUS RESERVOIR BAG & HOLDER is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K803059.

When did INTERSEPT* VENOUS RESERVOIR BAG & HOLDER receive FDA 510(k) clearance?

INTERSEPT* VENOUS RESERVOIR BAG & HOLDER received FDA 510(k) clearance on 1980-12-22, under 510(k) number K803059.

Who is the listed applicant for INTERSEPT* VENOUS RESERVOIR BAG & HOLDER?

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

What is the FDA product code for INTERSEPT* VENOUS RESERVOIR BAG & HOLDER?

The FDA product code for INTERSEPT* VENOUS RESERVOIR BAG & HOLDER is DTN.

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Other records listing Extracorporeal Medical Specialities, 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: 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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