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FDA 510(k)

THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500

K-Number: K012942 · 2001-11-05

ApplicantCirculatory Technology, Inc.
Decision Date2001-11-05
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 is the device name listed in this FDA 510(k) record. The listed applicant is Circulatory Technology, Inc.. It received FDA 510(k) clearance on 2001-11-05 under 510(k) number K012942. 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 THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500?

THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 is a medical device that received FDA 510(k) clearance on 2001-11-05. The listed applicant is Circulatory Technology, Inc.. The 510(k) number is K012942.

When did THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 receive FDA 510(k) clearance?

THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 received FDA 510(k) clearance on 2001-11-05, under 510(k) number K012942.

Who is the listed applicant for THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500?

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

What is the FDA product code for THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500?

The FDA product code for THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 is DTN.

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Other records listing Circulatory Technology, Inc. as applicant

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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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