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FDA 510(k)

Pacel Flow Directed Pacing Catheter

K-Number: K161873 · 2016-11-22

ApplicantSt Jude Medical
Decision Date2016-11-22
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pacel Flow Directed Pacing Catheter is a medical device manufactured by St Jude Medical. It received FDA 510(k) clearance on 2016-11-22 under approval number K161873. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pacel Flow Directed Pacing Catheter?

Pacel Flow Directed Pacing Catheter is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by St Jude Medical. The 510(k) number is K161873.

When was Pacel Flow Directed Pacing Catheter approved by the FDA?

Pacel Flow Directed Pacing Catheter received FDA 510(k) clearance on 2016-11-22, under approval number K161873.

What company makes Pacel Flow Directed Pacing Catheter?

Pacel Flow Directed Pacing Catheter is manufactured by St Jude Medical.

What is the FDA product code for Pacel Flow Directed Pacing Catheter?

The FDA product code for Pacel Flow Directed Pacing Catheter is LDF.

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Related Devices (Code: LDF)

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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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