Cleared Traditional

K191551 - RIST Cath Radial Access Long Sheath

K191551 is the FDA 510(k) clearance for RIST Cath Radial Access Long Sheath by Rist Neurovascular, Inc.. It is a Class 2 Neurology device (product code DQY) cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K191551 · Rist Neurovascular, Inc. · Neurology device
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Dec 2019
Decision
194d
Days
Class 2
Risk

K191551 is an FDA 510(k) clearance for the RIST Cath Radial Access Long Sheath. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Rist Neurovascular, Inc. (Miramar, US). The FDA issued a Cleared decision on December 23, 2019 after a review of 194 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 Rist Neurovascular, Inc. devices

Submission Details

510(k) Number K191551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2019
Decision Date December 23, 2019
Days to Decision 194 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
46d slower than avg
Panel avg: 148d · This submission: 194d
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 Consultant

Caraballo Consulting
Elena Jugo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQY Catheter, Percutaneous

All 573
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