FDA 510(k)

6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter

K-Number: K232190 · 2023-08-22

Decision Date2023-08-22

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2023-08-22 under 510(k) number K232190. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter?

6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter is a medical device that received FDA 510(k) clearance on 2023-08-22. The listed applicant is Medtronic Vascular. The 510(k) number is K232190.

When did 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter receive FDA 510(k) clearance?

6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter received FDA 510(k) clearance on 2023-08-22, under 510(k) number K232190.

Who is the listed applicant for 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter?

The FDA 510(k) record lists Medtronic Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter?

The FDA product code for 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter is DQY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02439775SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation SystemCOMPLETED NCT05198674SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTNACTIVE_NOT_RECRUITING NCT06907147SPYRAL GEMINI Pilot StudyRECRUITING NCT07115953Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled HypertensionRECRUITING

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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.