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

FDA 510(k)

NMI COAXIAL MICROINTRODUCER SET

K-Number: K132713 · 2013-09-27

ApplicantNavilyst Medical, Inc.
Decision Date2013-09-27
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NMI COAXIAL MICROINTRODUCER SET is the device name listed in this FDA 510(k) record. The listed applicant is Navilyst Medical, Inc.. It received FDA 510(k) clearance on 2013-09-27 under 510(k) number K132713. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NMI COAXIAL MICROINTRODUCER SET?

NMI COAXIAL MICROINTRODUCER SET is a medical device that received FDA 510(k) clearance on 2013-09-27. The listed applicant is Navilyst Medical, Inc.. The 510(k) number is K132713.

When did NMI COAXIAL MICROINTRODUCER SET receive FDA 510(k) clearance?

NMI COAXIAL MICROINTRODUCER SET received FDA 510(k) clearance on 2013-09-27, under 510(k) number K132713.

Who is the listed applicant for NMI COAXIAL MICROINTRODUCER SET?

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

What is the FDA product code for NMI COAXIAL MICROINTRODUCER SET?

The FDA product code for NMI COAXIAL MICROINTRODUCER SET is DRE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Navilyst Medical, 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.

K163452PICC Maximal Barrier Nursing KitK161866BioFlo Midline CatheterK151239NMI DUAL PORT IIK133264NMI PICC IIIK131694NMI PORT II CATHETERK131942NMI PICC III CATHETER, NMI HPICC III CATHETER

View all 25 devices →

Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, 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.

↑