Decision Date2008-08-28
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
POWERLOC CLEAR SAFETY INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2008-08-28 under 510(k) number K082306. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the POWERLOC CLEAR SAFETY INFUSION SET?
POWERLOC CLEAR SAFETY INFUSION SET is a medical device that received FDA 510(k) clearance on 2008-08-28. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K082306.
When did POWERLOC CLEAR SAFETY INFUSION SET receive FDA 510(k) clearance?
POWERLOC CLEAR SAFETY INFUSION SET received FDA 510(k) clearance on 2008-08-28, under 510(k) number K082306.
Who is the listed applicant for POWERLOC CLEAR SAFETY INFUSION SET?
The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for POWERLOC CLEAR SAFETY INFUSION SET?
The FDA product code for POWERLOC CLEAR SAFETY INFUSION SET is FPA.
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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.