Cleared Traditional

K191305 - Hereaeus Poseidon Microcatheter

K191305 is the FDA 510(k) clearance for Hereaeus Poseidon Microcatheter by Heraeus Medical Components, LLC. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K191305 · Heraeus Medical Components, LLC · Cardiovascular device
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Dec 2019
Decision
219d
Days
Class 2
Risk

K191305 is an FDA 510(k) clearance for the Hereaeus Poseidon Microcatheter. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Heraeus Medical Components, LLC (Plymouth, US). The FDA issued a Cleared decision on December 19, 2019 after a review of 219 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 Heraeus Medical Components, LLC devices

Submission Details

510(k) Number K191305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2019
Decision Date December 19, 2019
Days to Decision 219 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
94d slower than avg
Panel avg: 125d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 127
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K191305.
TRUSELECT Microcatheter
K201792 · Boston Scientific Corporation · Jul 2020
Bendit2.7 Steerable Microcatheter
K200582 · Bend IT Technologies, Ltd. · Jun 2020
Instylla Microcatheter
K200744 · Instylla, Inc. · Apr 2020
TriSalus Infusion System
K193107 · Trisalus Life Sciences · Dec 2019
Instylla Microcatheter
K191731 · Instylla, Inc. · Aug 2019
Multi-Sideport Catheter Infusion Set
K182071 · Cook Incorporated · Apr 2019