Cleared Traditional

K220280 - Arrow Stiffening Stylet

K220280 is an FDA 510(k) clearance for Arrow Stiffening Stylet, manufactured by Arrow International, LLC (A subsidiary of Teleflex, Inc.). The device is a Class 2 Cardiovascular device with product code DRB cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K220280 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
210d
Days
Class 2
Risk

K220280 is an FDA 510(k) clearance for the Arrow Stiffening Stylet. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by Arrow International, LLC (A subsidiary of Teleflex, Inc.) (Morrisville, US). The FDA issued a Cleared decision on August 30, 2022 after a review of 210 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1380 - 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. Standard predicate reliance. 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 Arrow International, LLC (A subsidiary of Teleflex, Inc.) devices

FDA 510(k) Submission Details - K220280

510(k) Number K220280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2022
Decision Date August 30, 2022
Days to Decision 210 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
85d slower than avg
Panel avg: 125d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRB Device Classification - Class 2, Special Controls

Product Code DRB Stylet, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1380
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 - DRB Stylet, Catheter

All 15
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K220280.
Biotronik Stylets
K191469 · Biotronik, Inc. · Aug 2019
GaltTWS
K182660 · Galt Medical Corp. · May 2019
Liberator Beacon Tip Locking Stylet
K170298 · Cook Incorporated · Oct 2017
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
K090163 · St Jude Medical · Apr 2009
SPECTRANETICS LLD CS, MODEL 518-039
K043401 · Spectranetics Corp. · Mar 2005
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · Medtronic Vascular · Apr 2001