Cleared Traditional

K212784 - TightRail Guardian Motorized Dilator Sheath (FDA 510(k) Clearance)

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

K212784 · Spectranetics, Inc. · Cardiovascular device
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Aug 2022
Decision
357d
Days
Class 2
Risk

K212784 is an FDA 510(k) clearance for the TightRail Guardian Motorized 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 August 24, 2022 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Spectranetics, Inc. devices

Submission Details

510(k) Number K212784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2021
Decision Date August 24, 2022
Days to Decision 357 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
232d slower than avg
Panel avg: 125d · This submission: 357d
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 K212784.
ProtekDilate Vascular Access Kit
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