Cleared Traditional

SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 (K031692) - FDA 510(k) Clearance

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

K031692 · Intra Luminal Therapeutics, Inc. · Cardiovascular device
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Aug 2003
Decision
81d
Days
Class 2
Risk

K031692 is an FDA 510(k) clearance for the SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Intra Luminal Therapeutics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on August 22, 2003 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight 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 Intra Luminal Therapeutics, Inc. devices

Submission Details

510(k) Number K031692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2003
Decision Date August 22, 2003
Days to Decision 81 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 125d · This submission: 81d
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 293
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