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FDA 510(k)

Paragon 8F Balloon Guide Catheter

K-Number: K232437 · 2023-10-13

ApplicantWallaby Medical
Decision Date2023-10-13
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Paragon 8F Balloon Guide Catheter is a medical device manufactured by Wallaby Medical. It received FDA 510(k) clearance on 2023-10-13 under approval number K232437. 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 Paragon 8F Balloon Guide Catheter?

Paragon 8F Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2023-10-13. It is manufactured by Wallaby Medical. The 510(k) number is K232437.

When was Paragon 8F Balloon Guide Catheter approved by the FDA?

Paragon 8F Balloon Guide Catheter received FDA 510(k) clearance on 2023-10-13, under approval number K232437.

What company makes Paragon 8F Balloon Guide Catheter?

Paragon 8F Balloon Guide Catheter is manufactured by Wallaby Medical.

What is the FDA product code for Paragon 8F Balloon Guide Catheter?

The FDA product code for Paragon 8F Balloon Guide Catheter is DQY.

Related Clinical Trials

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Other Devices by Wallaby Medical

K211697Esperance Aspiration Catheter System K223139Wallaby 017 Micro Catheter K240917Esperance 3+ Aspiration Catheter System K231056Esperance Distal Access Catheter

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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