Cleared Traditional

K191237 - CERENOVUS Large Bore Catheter

K191237 is the FDA 510(k) clearance for CERENOVUS Large Bore Catheter by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code DQY) cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K191237 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
184d
Days
Class 2
Risk

K191237 is an FDA 510(k) clearance for the CERENOVUS Large Bore Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on November 8, 2019 after a review of 184 days - an extended review 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: 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 Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K191237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2019
Decision Date November 08, 2019
Days to Decision 184 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
36d slower than avg
Panel avg: 148d · This submission: 184d
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 505
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K191237.
AXS Infinity LS Plus Long Sheath
K193034 · Stryker Neurovascular · Nov 2019
PG Pro Microcatheter
K192625 · MicroVention, Inc. A TERUMO Group Company · Nov 2019
Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool
K192996 · Biotronik, Inc. · Nov 2019
087 Balloon Guide Catheter System
K192525 · Q'Apel Medical, LLC · Oct 2019
Medtronic 6F Taiga Guiding Catheter
K192296 · Medtronic Vascular · Sep 2019
SelectFlex 072 Neurovascular Access System
K191664 · Q'Apel Medical · Aug 2019