Steerable Guide Catheter
K-Number: K161985 · 2016-08-07
ApplicantAbbott Vascular
Decision Date2016-08-07
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Steerable Guide Catheter is a medical device manufactured by Abbott Vascular. It received FDA 510(k) clearance on 2016-08-07 under approval number K161985. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Steerable Guide Catheter?
Steerable Guide Catheter is a medical device that received FDA 510(k) clearance on 2016-08-07. It is manufactured by Abbott Vascular. The 510(k) number is K161985.
When was Steerable Guide Catheter approved by the FDA?
Steerable Guide Catheter received FDA 510(k) clearance on 2016-08-07, under approval number K161985.
What company makes Steerable Guide Catheter?
Steerable Guide Catheter is manufactured by Abbott Vascular.
What is the FDA product code for Steerable Guide Catheter?
The FDA product code for Steerable Guide Catheter is DRA.
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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.