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FDA 510(k)

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

K-Number: K232190 · 2023-08-22

ApplicantMedtronic Vascular
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 a medical device manufactured by Medtronic Vascular. It received FDA 510(k) clearance on 2023-08-22 under approval 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. It is manufactured by Medtronic Vascular. The 510(k) number is K232190.

When was 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter approved by the FDA?

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

What company makes 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 manufactured by Medtronic Vascular.

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.

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Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire Medical, Inc.

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.

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