Cleared Traditional

K221414 - ENROUTE Enflate Transcarotid RX Balloon...

K221414 is an FDA 510(k) clearance for ENROUTE Enflate Transcarotid RX Balloon..., manufactured by Silk Road Medical, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 109-day FDA review.

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

FDA 510(k) Submission Details - K221414

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.

LIT Device Classification - Class 2, Special Controls

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 263
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K221414.
Passeo-35 Xeo Peripheral Dilatation Catheter
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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
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K212215 · Brosmed Medical Co., Ltd. · Jul 2022
Oscar Peripheral Multifunctional Catheter system
K214038 · Biotronik, Inc. · Jul 2022