Cleared Traditional

TracStar LDP Large Distal Platform (K240948) - FDA 510(k) Clearance

Also marketed or referenced as:
Zoom 88 Large Distal Platform Zoom 88 Large Distal Platform Support

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

K240948 · Imperative Care, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
59d
Days
Class 2
Risk

K240948 is an FDA 510(k) clearance for the TracStar LDP Large Distal Platform. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Imperative Care, Inc. (Campbell, US). The FDA issued a Cleared decision on June 6, 2024 after a review of 59 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 Imperative Care, Inc. devices

Submission Details

510(k) Number K240948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2024
Decision Date June 06, 2024
Days to Decision 59 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
89d faster than avg
Panel avg: 148d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K240948.
CEREGLIDE 42 Intermediate Catheter
K241244 · Cerenovus, Inc. · Oct 2024
8F Modified Sheath System
K240529 · Route 92 Medical, Inc. · Oct 2024
Next Generation Access Catheter
K234074 · Balt USA, LLC · Jul 2024
Wedge XL Delivery Catheter
K232542 · MicroVention, Inc. · May 2024
CEREGLIDE 92 Catheter System
K233982 · Cerenovus, Inc. · May 2024
EMBOGUARD Balloon Guide Catheter
K233924 · Neuravi Limited · Apr 2024