Cleared Traditional

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

K231279 · Ablative Solutions, Inc. · Cardiovascular

Jul 2023

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K231279 is an FDA 510(k) clearance for the Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Ablative Solutions, Inc. (Wakefield, US). The FDA issued a Cleared decision on July 5, 2023, 63 days after receiving the submission on May 3, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number	K231279 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 2023
Decision Date	July 05, 2023
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF