Cleared Traditional

CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm (K192804) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192804 · Medos International SARL · Neurology device
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Feb 2020
Decision
149d
Days
Class 2
Risk

K192804 is an FDA 510(k) clearance for the CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA G.... Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on February 27, 2020 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medos International SARL devices

Submission Details

510(k) Number K192804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2019
Decision Date February 27, 2020
Days to Decision 149 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 148d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QJP Catheter, Percutaneous, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures
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 Neurology devices follow this clearance model.

Regulatory Peers - QJP Catheter, Percutaneous, Neurovasculature

All 90
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K192804.
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