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FDA 510(k)

ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter

K-Number: K221414 · 2022-09-02

ApplicantSilk Road Medical, Inc.
Decision Date2022-09-02
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Silk Road Medical, Inc.. It received FDA 510(k) clearance on 2022-09-02 under 510(k) number K221414. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter?

ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Silk Road Medical, Inc.. The 510(k) number is K221414.

When did ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter receive FDA 510(k) clearance?

ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter received FDA 510(k) clearance on 2022-09-02, under 510(k) number K221414.

Who is the listed applicant for ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter?

The FDA 510(k) record lists Silk Road Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter?

The FDA product code for ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter is LIT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05509296Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery DiseaseCOMPLETEDNCT06832631VITUS Post-Market RegistryACTIVE_NOT_RECRUITINGNCT07397390an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified LesionsENROLLING_BY_INVITATION

Other records listing Silk Road Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230402ENROUTE® Transcarotid Neuroprotection SystemK153485ENROUTE Transcarotid Neuroprotection System

Related Devices (Code: LIT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, Inc.K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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