Decision Date2011-07-21
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
INFUSION SET FOR POWERPICC SOLO 2 CATHETER 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 2011-07-21 under 510(k) number K102405. 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 INFUSION SET FOR POWERPICC SOLO 2 CATHETER?
INFUSION SET FOR POWERPICC SOLO 2 CATHETER is a medical device that received FDA 510(k) clearance on 2011-07-21. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K102405.
When did INFUSION SET FOR POWERPICC SOLO 2 CATHETER receive FDA 510(k) clearance?
INFUSION SET FOR POWERPICC SOLO 2 CATHETER received FDA 510(k) clearance on 2011-07-21, under 510(k) number K102405.
Who is the listed applicant for INFUSION SET FOR POWERPICC SOLO 2 CATHETER?
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 INFUSION SET FOR POWERPICC SOLO 2 CATHETER?
The FDA product code for INFUSION SET FOR POWERPICC SOLO 2 CATHETER 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.