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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 the device name listed in this FDA 510(k) record. The listed applicant is Abbott (St. Jude Medical). It received FDA 510(k) clearance on 2020-06-03 under 510(k) 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. The listed applicant is Abbott (St. Jude Medical). The 510(k) number is K200721.

When did Agilis HisPro Steerable Catheter With Electrodes receive FDA 510(k) clearance?

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

Who is the listed applicant for Agilis HisPro Steerable Catheter With Electrodes?

The FDA 510(k) record lists Abbott (St. Jude Medical) as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Abbott (St. Jude Medical) as applicant

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.

K212206Jot Dx Insertable Cardiac MonitorK202876Confirm Rx Insertable Cardiac MonitorK202888Confirm Rx Insertable Cardiac MonitorK193310myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)K190295Confirm Rx Insertable Cardiac Monitor

Related Devices (Code: DQY)

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.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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