Cleared Traditional

ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter (K221414) - FDA 510(k) Clearance

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

K221414 · Silk Road Medical, Inc. · Cardiovascular device
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Sep 2022
Decision
109d
Days
Class 2
Risk

K221414 is an FDA 510(k) clearance for the ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Silk Road Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 2, 2022 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Silk Road Medical, Inc. devices

Submission Details

510(k) Number K221414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2022
Decision Date September 02, 2022
Days to Decision 109 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
16d faster than avg
Panel avg: 125d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 154
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K221414.
Passeo-35 Xeo Peripheral Dilatation Catheter
K222065 · Biotronik, Inc. · Feb 2023
Highlander™ 014 PTA Balloon Dilatation Catheter
K223177 · C.R. Bard, Inc. · Jan 2023
PTA Balloon Dilatation Catheter
K221245 · Kossel Medtech (Suzhou) Co., Ltd. · Dec 2022
SABER .014 PTA Dilatation Catheter
K221832 · Cordis US Corp · Aug 2022
Tiche PTA Balloon Dilatation Catheter
K212215 · Brosmed Medical Co., Ltd. · Jul 2022
Oscar Peripheral Multifunctional Catheter system
K214038 · Biotronik, Inc. · Jul 2022