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)

MEDAMICUS PERCUTANEOUS INTRODUCER

K-Number: K951313 · 1995-06-27

ApplicantMedamicus, Inc.
Decision Date1995-06-27
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDAMICUS PERCUTANEOUS INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Medamicus, Inc.. It received FDA 510(k) clearance on 1995-06-27 under 510(k) number K951313. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDAMICUS PERCUTANEOUS INTRODUCER?

MEDAMICUS PERCUTANEOUS INTRODUCER is a medical device that received FDA 510(k) clearance on 1995-06-27. The listed applicant is Medamicus, Inc.. The 510(k) number is K951313.

When did MEDAMICUS PERCUTANEOUS INTRODUCER receive FDA 510(k) clearance?

MEDAMICUS PERCUTANEOUS INTRODUCER received FDA 510(k) clearance on 1995-06-27, under 510(k) number K951313.

Who is the listed applicant for MEDAMICUS PERCUTANEOUS INTRODUCER?

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

What is the FDA product code for MEDAMICUS PERCUTANEOUS INTRODUCER?

The FDA product code for MEDAMICUS PERCUTANEOUS INTRODUCER is DYB.

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 Medamicus, 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.

K040150MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCERK030905MEDAMICUS FLOWGUARD PEELABLE INTRODUCERK022689MODIFICATION TO MEDAMICUS AXIA RSNK021004VALVED PEELABLE INTRODUCERK020563MEDAMICUS AXIA RSNK013120PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18

View all 20 devices →

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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.

↑