Cleared Traditional

Paragon 8F Balloon Guide Catheter (K232437) - FDA 510(k) Clearance

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

K232437 · Wallaby Medical · Neurology device
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Oct 2023
Decision
60d
Days
Class 2
Risk

K232437 is an FDA 510(k) clearance for the Paragon 8F Balloon Guide Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Wallaby Medical (Laguna Hills, US). The FDA issued a Cleared decision on October 13, 2023 after a review of 60 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 Wallaby Medical devices

Submission Details

510(k) Number K232437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2023
Decision Date October 13, 2023
Days to Decision 60 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 148d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 316
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K232437.
TriSalus TriGuideTM Guiding Catheter
K233858 · Trisalus Life Sciences · Dec 2023
SENDERO Microcatheter
K231600 · Okami Medical, Inc. · Nov 2023
091 Balloon Guide Catheter
K231629 · Eosolutions, Corp. · Oct 2023
Microcatheter
K232647 · Surmodics,Inc. · Sep 2023
Amulet™ Steerable Delivery Sheath
K232690 · Abbott Medical · Sep 2023
Ventrax™ Delivery System (VTR851)
K231246 · Merit Medical Systems, Inc. · Aug 2023