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FDA 510(k)

DAVOL PLUME FILTER (5541420)

K-Number: K964211 · 1996-12-02

ApplicantDavol Inc., Sub. C. R. Bard, Inc.
Decision Date1996-12-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DAVOL PLUME FILTER (5541420) is the device name listed in this FDA 510(k) record. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. It received FDA 510(k) clearance on 1996-12-02 under 510(k) number K964211. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAVOL PLUME FILTER (5541420)?

DAVOL PLUME FILTER (5541420) is a medical device that received FDA 510(k) clearance on 1996-12-02. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. The 510(k) number is K964211.

When did DAVOL PLUME FILTER (5541420) receive FDA 510(k) clearance?

DAVOL PLUME FILTER (5541420) received FDA 510(k) clearance on 1996-12-02, under 510(k) number K964211.

Who is the listed applicant for DAVOL PLUME FILTER (5541420)?

The FDA 510(k) record lists Davol Inc., Sub. C. R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DAVOL PLUME FILTER (5541420)?

The FDA product code for DAVOL PLUME FILTER (5541420) is GEX. This falls under the Gastroenterology category.

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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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