FDA 510(k)

BIB Stent Placement Catheter

K-Number: K161451 · 2016-09-22

Decision Date2016-09-22

Product CodeNVM

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BIB Stent Placement Catheter is the device name listed in this FDA 510(k) record. The listed applicant is NuMED, Inc.. It received FDA 510(k) clearance on 2016-09-22 under 510(k) number K161451. 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 2016-09-22. The listed applicant is NuMED, Inc.. The 510(k) number is K161451.

When did BIB Stent Placement Catheter receive FDA 510(k) clearance?

BIB Stent Placement Catheter received FDA 510(k) clearance on 2016-09-22, under 510(k) number K161451.

Who is the listed applicant for BIB Stent Placement Catheter?

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

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

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

Other records listing NuMED, 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.

PMA P150028Aortic stent K213915BIB Stent Placement Catheter K211910Z-6 Atrioseptostomy Catheter K211134BIB Stent Placement Catheter K190974D'Vill Introducer K171206D'Vill Introducer

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Related Devices (Code: NVM)

K213915BIB Stent Placement CatheterNuMED, Inc.K211134BIB Stent Placement CatheterNuMED, Inc.K160889BIB 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.