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FDA 510(k)

Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm

K-Number: K231279 · 2023-07-05

ApplicantAblative Solutions, Inc.
Decision Date2023-07-05
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm is a medical device manufactured by Ablative Solutions, Inc.. It received FDA 510(k) clearance on 2023-07-05 under approval number K231279. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm?

Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm is a medical device that received FDA 510(k) clearance on 2023-07-05. It is manufactured by Ablative Solutions, Inc.. The 510(k) number is K231279.

When was Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm approved by the FDA?

Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm received FDA 510(k) clearance on 2023-07-05, under approval number K231279.

What company makes Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm?

Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm is manufactured by Ablative Solutions, Inc..

What is the FDA product code for Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm?

The FDA product code for Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm is KRA.

Related Clinical Trials

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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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