Cleared Special

BOSS 8F Balloon Guide Catheter (K203840) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K203840 · Marblehead Medical, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2021
Decision
28d
Days
Class 2
Risk

K203840 is an FDA 510(k) clearance for the BOSS 8F Balloon Guide Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Marblehead Medical, LLC (Rochester Mn, US). The FDA issued a Cleared decision on January 28, 2021 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Marblehead Medical, LLC devices

Submission Details

510(k) Number K203840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2020
Decision Date January 28, 2021
Days to Decision 28 days
Submission Type Special
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
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K203840.
SelectFlex Neurovascular Access System Family
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Route 92 Medical Full Length 088 Access System
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K203764 · Imperative Care, Inc. · Mar 2021
Route 92 Medical 070 Access System
K203043 · Route 92 Medical, Inc. · Nov 2020
RIST Radial Access Catheter
K201682 · Rist Neurovascular, Inc. · Sep 2020
Route 92 Medical 088 Access System
K201518 · Route 92 Medical · Aug 2020