Decision Date1978-12-20
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CATHETER, DIGITAL POSITRAL II 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 1978-12-20 under 510(k) number K782082. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CATHETER, DIGITAL POSITRAL II?
CATHETER, DIGITAL POSITRAL II is a medical device that received FDA 510(k) clearance on 1978-12-20. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K782082.
When did CATHETER, DIGITAL POSITRAL II receive FDA 510(k) clearance?
CATHETER, DIGITAL POSITRAL II received FDA 510(k) clearance on 1978-12-20, under 510(k) number K782082.
Who is the listed applicant for CATHETER, DIGITAL POSITRAL II?
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 CATHETER, DIGITAL POSITRAL II?
The FDA product code for CATHETER, DIGITAL POSITRAL II is DQO.
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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.