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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 a medical device manufactured by Silk Road Medical, Inc.. It received FDA 510(k) clearance on 2022-09-02 under approval 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. It is manufactured by Silk Road Medical, Inc.. The 510(k) number is K221414.

When was ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter approved by the FDA?

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

What company makes ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter?

ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter is manufactured by Silk Road Medical, Inc..

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

NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_RECRUITING NCT06492174 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort ACTIVE_NOT_RECRUITING NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING NCT07414771 Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP) NOT_YET_RECRUITING

Other Devices by Silk Road Medical, Inc.

K153485ENROUTE Transcarotid Neuroprotection System

Related Devices (Code: LIT)

K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K162316Pirouette 014Arravasc, Ltd. K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018Boston Scientific Corporation K161427Pirouette 035Arravasc Limited K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160004Crosstella OTWKANEKA Corporation

Official Source

View on FDA Database →

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

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