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FDA 510(k)

PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE

K-Number: K042062 · 2004-09-30

ApplicantBard Peripheral Vascular, Inc.
Decision Date2004-09-30
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2004-09-30 under 510(k) number K042062. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE?

PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE is a medical device that received FDA 510(k) clearance on 2004-09-30. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K042062.

When did PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE receive FDA 510(k) clearance?

PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE received FDA 510(k) clearance on 2004-09-30, under 510(k) number K042062.

Who is the listed applicant for PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE?

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

What is the FDA product code for PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE?

The FDA product code for PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE is KCT.

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Related Devices (Code: KCT)

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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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