Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MAMBA and MAMBA FLEX Microcatheters

K-Number: K171452 · 2017-08-21

ApplicantBoston Scientific Corporation
Decision Date2017-08-21
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAMBA and MAMBA FLEX Microcatheters is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-08-21 under approval number K171452. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAMBA and MAMBA FLEX Microcatheters?

MAMBA and MAMBA FLEX Microcatheters is a medical device that received FDA 510(k) clearance on 2017-08-21. It is manufactured by Boston Scientific Corporation. The 510(k) number is K171452.

When was MAMBA and MAMBA FLEX Microcatheters approved by the FDA?

MAMBA and MAMBA FLEX Microcatheters received FDA 510(k) clearance on 2017-08-21, under approval number K171452.

What company makes MAMBA and MAMBA FLEX Microcatheters?

MAMBA and MAMBA FLEX Microcatheters is manufactured by Boston Scientific Corporation.

What is the FDA product code for MAMBA and MAMBA FLEX Microcatheters?

The FDA product code for MAMBA and MAMBA FLEX Microcatheters is DQY.

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: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire 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.

↑