FDA 510(k)

Nanostim Introducer Kit

K-Number: K161102 · 2016-05-19

Decision Date2016-05-19

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Nanostim Introducer Kit is a medical device manufactured by St. Jude Medical, Inc.. It received FDA 510(k) clearance on 2016-05-19 under approval number K161102. 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 Nanostim Introducer Kit?

Nanostim Introducer Kit is a medical device that received FDA 510(k) clearance on 2016-05-19. It is manufactured by St. Jude Medical, Inc.. The 510(k) number is K161102.

When was Nanostim Introducer Kit approved by the FDA?

Nanostim Introducer Kit received FDA 510(k) clearance on 2016-05-19, under approval number K161102.

What company makes Nanostim Introducer Kit?

Nanostim Introducer Kit is manufactured by St. Jude Medical, Inc..

What is the FDA product code for Nanostim Introducer Kit?

The FDA product code for Nanostim Introducer Kit is DYB.

Other Devices by St. Jude Medical, Inc.

K161171PressureWire X Guidewire K160716The Nanostim Introducer Kit K163407Confirm Rx Insertable Cardiac Monitor (ICM) System K172393Advisor HD Grid Mapping Catheter, Sensor Enabled PMA P880006Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Related Devices (Code: DYB)

K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC K162097InTRAkitMedtronic Vascular K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc. K153771TXM Guiding SheathTexasmedical Technologies, Inc. K162184Edwards eSheath Introducer SetEdward Lifesciences K153494HQS Introducer (Model 2064-HQS)Alseal

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.