Decision Date1992-08-03
Product CodeMEA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
BARD PCA II PUMP WITH PROGRAM CARTRIDGES 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 1992-08-03 under 510(k) number K921994. The device is classified under product code MEA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BARD PCA II PUMP WITH PROGRAM CARTRIDGES?
BARD PCA II PUMP WITH PROGRAM CARTRIDGES is a medical device that received FDA 510(k) clearance on 1992-08-03. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K921994.
When did BARD PCA II PUMP WITH PROGRAM CARTRIDGES receive FDA 510(k) clearance?
BARD PCA II PUMP WITH PROGRAM CARTRIDGES received FDA 510(k) clearance on 1992-08-03, under 510(k) number K921994.
Who is the listed applicant for BARD PCA II PUMP WITH PROGRAM CARTRIDGES?
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 BARD PCA II PUMP WITH PROGRAM CARTRIDGES?
The FDA product code for BARD PCA II PUMP WITH PROGRAM CARTRIDGES is MEA.
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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.