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FDA 510(k)

Agilis HisPro Steerable Catheter With Electrodes

K-Number: K200721 · 2020-06-03

ApplicantAbbott (St. Jude Medical)
Decision Date2020-06-03
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Agilis HisPro Steerable Catheter With Electrodes is a medical device manufactured by Abbott (St. Jude Medical). It received FDA 510(k) clearance on 2020-06-03 under approval number K200721. 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 Agilis HisPro Steerable Catheter With Electrodes?

Agilis HisPro Steerable Catheter With Electrodes is a medical device that received FDA 510(k) clearance on 2020-06-03. It is manufactured by Abbott (St. Jude Medical). The 510(k) number is K200721.

When was Agilis HisPro Steerable Catheter With Electrodes approved by the FDA?

Agilis HisPro Steerable Catheter With Electrodes received FDA 510(k) clearance on 2020-06-03, under approval number K200721.

What company makes Agilis HisPro Steerable Catheter With Electrodes?

Agilis HisPro Steerable Catheter With Electrodes is manufactured by Abbott (St. Jude Medical).

What is the FDA product code for Agilis HisPro Steerable Catheter With Electrodes?

The FDA product code for Agilis HisPro Steerable Catheter With Electrodes is DQY.

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Related Devices (Code: DQY)

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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.

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