Cleared Traditional

K200910 - BOSS Balloon Guide Catheter

K200910 is the FDA 510(k) clearance for BOSS Balloon Guide Catheter by Marblehead Medical. It is a Class 2 Neurology device (product code QJP) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K200910 · Marblehead Medical · Neurology device
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May 2020
Decision
26d
Days
Class 2
Risk

K200910 is an FDA 510(k) clearance for the BOSS Balloon Guide Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Marblehead Medical (Maple Grove, US). The FDA issued a Cleared decision on May 2, 2020 after a review of 26 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Marblehead Medical devices

Submission Details

510(k) Number K200910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2020
Decision Date May 02, 2020
Days to Decision 26 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 148d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K200910.
Route 92 Medical 088 Access System
K201518 · Route 92 Medical · Aug 2020
Anchor Dual Lumen Guidewire Catheter
K201076 · Aqure Medical, Inc. · Aug 2020
RIST Radial Access Catheter
K200417 · Rist Neurovascular, Inc. · May 2020
Route 92 Medical 088 Access System, 110 cm
K200121 · Route 92 Medical, Inc. · Apr 2020
CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm
K192804 · Medos International SARL · Feb 2020
AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
K200206 · Stryker Neurovascular · Feb 2020