Cleared Traditional

K191305 - Hereaeus Poseidon Microcatheter

K191305 is an FDA 510(k) clearance for Hereaeus Poseidon Microcatheter, manufactured by Heraeus Medical Components, LLC. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K191305

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.

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 149
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