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FDA 510(k)

KOALA VASCULAR CLAMPS AND INSERTS

K-Number: K980002 · 1998-06-18

ApplicantBoss Instruments, Ltd.
Decision Date1998-06-18
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KOALA VASCULAR CLAMPS AND INSERTS is the device name listed in this FDA 510(k) record. The listed applicant is Boss Instruments, Ltd.. It received FDA 510(k) clearance on 1998-06-18 under 510(k) number K980002. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOALA VASCULAR CLAMPS AND INSERTS?

KOALA VASCULAR CLAMPS AND INSERTS is a medical device that received FDA 510(k) clearance on 1998-06-18. The listed applicant is Boss Instruments, Ltd.. The 510(k) number is K980002.

When did KOALA VASCULAR CLAMPS AND INSERTS receive FDA 510(k) clearance?

KOALA VASCULAR CLAMPS AND INSERTS received FDA 510(k) clearance on 1998-06-18, under 510(k) number K980002.

Who is the listed applicant for KOALA VASCULAR CLAMPS AND INSERTS?

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

What is the FDA product code for KOALA VASCULAR CLAMPS AND INSERTS?

The FDA product code for KOALA VASCULAR CLAMPS AND INSERTS is DXC.

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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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