Cleared Traditional

K140637 - PEREGRINE SYSTEM INFUSION CATHETER

K140637 is an FDA 510(k) clearance for PEREGRINE SYSTEM INFUSION CATHETER, manufactured by Ablative Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K140637 · Ablative Solutions, Inc. · Cardiovascular device
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Mar 2014
Decision
14d
Days
Class 2
Risk

K140637 is an FDA 510(k) clearance for the PEREGRINE SYSTEM INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Ablative Solutions, Inc. (Menlo Park, US). The FDA issued a Cleared decision on March 26, 2014 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ablative Solutions, Inc. devices

FDA 510(k) Submission Details - K140637

510(k) Number K140637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2014
Decision Date March 26, 2014
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KRA Catheter, Continuous Flush

All 162
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K140637.
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ND NABIL DIB INFUSION CATHETER
K130569 · Translational Research Institute · Nov 2013
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K132947 · Boston Scientific Corp · Oct 2013