Cleared Traditional

K212784 - TightRail Guardian Motorized Dilator Sheath

K212784 is an FDA 510(k) clearance for TightRail Guardian Motorized Dilator Sheath, manufactured by Spectranetics, Inc.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K212784 · Spectranetics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K212784

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.

DRE Device Classification - Class 2, Special Controls

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 50
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K212784.
VersaCross Connect™ Transseptal Dilator
K233647 · Baylis Medical Company, Inc. · Dec 2023
Micro Ace™ Advanced Micro Access System
K232609 · Merit Medical Systems, Inc. · Sep 2023
TightRail Guardian Motorized Dilator Sheath, 9 French (575-009)
K223472 · Spectranetics, Inc. · Dec 2022
Xtractor device
K211679 · Xcardia Innovation , Ltd. · Feb 2022
Endovascular Dilator and Sets
K210734 · Cook Incorporated · Apr 2021
ExpanSure Large Access Transseptal Dilator
K201288 · Baylis Medical Company, Inc. · Jun 2020