FDA 510(k)

FARADRIVE Steerable Sheath

K-Number: K233248 · 2023-12-11

Decision Date2023-12-11

Product CodeDRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FARADRIVE Steerable Sheath is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-12-11 under approval number K233248. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FARADRIVE Steerable Sheath?

FARADRIVE Steerable Sheath is a medical device that received FDA 510(k) clearance on 2023-12-11. It is manufactured by Boston Scientific Corporation. The 510(k) number is K233248.

When was FARADRIVE Steerable Sheath approved by the FDA?

FARADRIVE Steerable Sheath received FDA 510(k) clearance on 2023-12-11, under approval number K233248.

What company makes FARADRIVE Steerable Sheath?

FARADRIVE Steerable Sheath is manufactured by Boston Scientific Corporation.

What is the FDA product code for FARADRIVE Steerable Sheath?

The FDA product code for FARADRIVE Steerable Sheath is DRA.

Related Clinical Trials

NCT04674969 Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature RECRUITING NCT04200937 IT Matters: The Erectile Restoration Registry ENROLLING_BY_INVITATION NCT02686125 Vercise™ DBS Dystonia Prospective Study RECRUITING NCT04032470 Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET) RECRUITING NCT03735667 ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement ACTIVE_NOT_RECRUITING

Other Devices by Boston Scientific Corporation

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete K163174Emerge PTCA Dilatation Catheter 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 0.018 K162404Express SD Biliary Monorail Premounted Stent System K160823NC Quantum Apex PTCA Dilatation Catheter K160514OptiCross 18, 30 MHz Peripheral Imaging Catheter

View all 176 devices →

Related Devices (Code: DRA)

K160919Hansen Medical Magellan Robotic Catheter 9FrHansen Medical, Inc. K161985Steerable Guide CatheterAbbott Vascular K152310HeartLight Deflectable SheathCardiofocus, Inc. K153304Hansen Medical Magellan Robotic Catheter eKitHansen Medical, Inc. K172394Steerable Guide CatheterAbbott Vascular K162925AcQGuide Steerable SheathAcutus Medical, Inc.

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.