Cleared Traditional

K171081 - Guider Catheter Introducer

K171081 is an FDA 510(k) clearance for Guider Catheter Introducer, manufactured by Rhythm Xience, Inc. (Rxi). The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K171081 · Rhythm Xience, Inc. (Rxi) · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
28d
Days
Class 2
Risk

K171081 is an FDA 510(k) clearance for the Guider Catheter Introducer. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Rhythm Xience, Inc. (Rxi) (Eden Prairie, US). The FDA issued a Cleared decision on May 9, 2017 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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.

FDA 510(k) Submission Details - K171081

510(k) Number K171081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2017
Decision Date May 09, 2017
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 - DYB Introducer, Catheter

All 662
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K171081.
Mini Stick ENVI Non-Vascular Introducer Kit
K170775 · AngioDynamics, Inc. · Jul 2017
VenaCure EVLT NeverTouch Direct Introducer Sheath
K170695 · AngioDynamics, Inc. · May 2017
EpiAccess System
K170831 · Epiep, Inc. · May 2017
HeartSpan Steerable Sheath Introducer
K170668 · Merit Medical Systems, Inc. · Apr 2017
Vado Steerable Sheath
K160721 · Kalila Medical, Inc. · Mar 2017
Flextra Steerable Introducer
K170373 · Rhythm Xience, Inc. (Rxi) · Feb 2017