Cleared Traditional

K161333 - TightRail Sub-C Rotating Dilator Sheath (FDA 510(k) Clearance)

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

K161333 · Spectranetics, Inc. · Cardiovascular device
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Jul 2016
Decision
57d
Days
Class 2
Risk

K161333 is an FDA 510(k) clearance for the TightRail Sub-C Rotating Dilator Sheath. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Spectranetics, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on July 8, 2016 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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 Spectranetics, Inc. devices

Submission Details

510(k) Number K161333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2016
Decision Date July 08, 2016
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 103
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K161333.
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K253616 · Sorin Group Italia S.R.L. · Dec 2025
VersaCross Connect™ Transseptal Dilator
K251325 · Baylis Medical Company, Inc. · May 2025
Micro Ace Gold Advanced Micro Access System
K242229 · Merit Medical Systems, Inc. · Jan 2025
VersaCross Connect™ Transseptal Dilator
K241720 · Baylis Medical Company, Inc. · Jul 2024
VersaCross Connect™ Transseptal Dilator
K233647 · Baylis Medical Company, Inc. · Dec 2023
Micro Ace™ Advanced Micro Access System
K232609 · Merit Medical Systems, Inc. · Sep 2023