Cleared Traditional

K222603 - 6F Wallaby Long Sheath

K222603 is an FDA 510(k) clearance for 6F Wallaby Long Sheath, manufactured by Wallaby Medical, Inc.. The device is a Class 2 Neurology device with product code DQY cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K222603 · Wallaby Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
185d
Days
Class 2
Risk

K222603 is an FDA 510(k) clearance for the 6F Wallaby Long Sheath. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Wallaby Medical, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on March 2, 2023 after a review of 185 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 Wallaby Medical, Inc. devices

FDA 510(k) Submission Details - K222603

510(k) Number K222603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2022
Decision Date March 02, 2023
Days to Decision 185 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
37d slower than avg
Panel avg: 148d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

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 621
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K222603.
Stingray LP Catheter
K231176 · Boston Scientific · May 2023
RayFlow
K222023 · Hexacath · Apr 2023
CPS Locator 3D Delivery Catheter
K230363 · CenterPoint Systems, LLC · Mar 2023
ISAAC Neurovascular Navigation Catheter
K222115 · MicroVention, Inc. · Jan 2023
SelectSite C304 Deflectable Catheter System, C315 Delivery System
K223178 · Medtronic · Nov 2022
Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system
K222873 · Medtronic · Nov 2022