Cleared Traditional

K182918 - Ballast 088 Long Sheath

K182918 is an FDA 510(k) clearance for Ballast 088 Long Sheath, manufactured by Balt USA, LLC. The device is a Class 2 Neurology device with product code DQY cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K182918 · Balt USA, LLC · Neurology device
Download Printable Device Report (PDF)
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Mar 2019
Decision
153d
Days
Class 2
Risk

K182918 is an FDA 510(k) clearance for the Ballast 088 Long Sheath. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on March 21, 2019 after a review of 153 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 Balt USA, LLC devices

FDA 510(k) Submission Details - K182918

510(k) Number K182918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2018
Decision Date March 21, 2019
Days to Decision 153 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
5d slower than avg
Panel avg: 148d · This submission: 153d
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 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K182918.
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K190401 · Boston Scientific Corporation · Mar 2019