Pinpoint GT Introducer Needle
K-Number: K162769 · 2016-11-04
ApplicantC.R. Bard, Inc.
Decision Date2016-11-04
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Pinpoint GT Introducer Needle is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-11-04 under approval number K162769. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pinpoint GT Introducer Needle?
Pinpoint GT Introducer Needle is a medical device that received FDA 510(k) clearance on 2016-11-04. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K162769.
When was Pinpoint GT Introducer Needle approved by the FDA?
Pinpoint GT Introducer Needle received FDA 510(k) clearance on 2016-11-04, under approval number K162769.
What company makes Pinpoint GT Introducer Needle?
Pinpoint GT Introducer Needle is manufactured by C.R. Bard, Inc..
What is the FDA product code for Pinpoint GT Introducer Needle?
The FDA product code for Pinpoint GT Introducer Needle is DYB.
Related Clinical Trials
Other Devices by C.R. Bard, Inc.
Related Devices (Code: DYB)
K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC
K162097InTRAkitMedtronic Vascular
K153771TXM Guiding SheathTexasmedical Technologies, Inc.
K162184Edwards eSheath Introducer SetEdward Lifesciences
K153494HQS Introducer (Model 2064-HQS)Alseal
K152913GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleCreganna Medical Aslo Business AS Cregganna Tactx Medical
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.