Cleared Traditional

K213442 - Extroducer Infusion Catheter System

K213442 is an FDA 510(k) clearance for Extroducer Infusion Catheter System, manufactured by SmartWise Sweden AB. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K213442 · SmartWise Sweden AB · Cardiovascular device
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Jun 2022
Decision
228d
Days
Class 2
Risk

K213442 is an FDA 510(k) clearance for the Extroducer Infusion Catheter System. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by SmartWise Sweden AB (Tullinge, SE). The FDA issued a Cleared decision on June 10, 2022 after a review of 228 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all SmartWise Sweden AB devices

FDA 510(k) Submission Details - K213442

510(k) Number K213442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2021
Decision Date June 10, 2022
Days to Decision 228 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 125d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - KRA Catheter, Continuous Flush

All 130
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K213442.
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