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)

BIB Stent Placement Catheter

K-Number: K213915 · 2022-01-12

ApplicantNuMED, Inc.
Decision Date2022-01-12
Product CodeNVM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIB Stent Placement Catheter is a medical device manufactured by NuMED, Inc.. It received FDA 510(k) clearance on 2022-01-12 under approval number K213915. The device is classified under product code NVM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIB Stent Placement Catheter?

BIB Stent Placement Catheter is a medical device that received FDA 510(k) clearance on 2022-01-12. It is manufactured by NuMED, Inc.. The 510(k) number is K213915.

When was BIB Stent Placement Catheter approved by the FDA?

BIB Stent Placement Catheter received FDA 510(k) clearance on 2022-01-12, under approval number K213915.

What company makes BIB Stent Placement Catheter?

BIB Stent Placement Catheter is manufactured by NuMED, Inc..

What is the FDA product code for BIB Stent Placement Catheter?

The FDA product code for BIB Stent Placement Catheter is NVM.

Related Clinical Trials

NCT06394739 RevCore for In Stent Thrombosis RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT05147363 Shockwave: Disruption for A Better Fit WITHDRAWN NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)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 NCT05546372 Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma RECRUITING

Other Devices by NuMED, Inc.

K161451BIB Stent Placement Catheter K160598REBOA Balloon Catheter K160889BIB Stent Placement Catheter K171206D'Vill Introducer K190974D'Vill Introducer K211910Z-6 Atrioseptostomy Catheter

View all 9 devices →

Related Devices (Code: NVM)

K161451BIB Stent Placement CatheterNuMED, Inc. K160889BIB Stent Placement CatheterNuMED, Inc. K211134BIB Stent Placement CatheterNuMED, 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.

↑