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)

INSTRUMENT DAMPING PORT

K-Number: K011373 · 2001-10-12

ApplicantMedcanica, Inc.
Decision Date2001-10-12
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INSTRUMENT DAMPING PORT is the device name listed in this FDA 510(k) record. The listed applicant is Medcanica, Inc.. It received FDA 510(k) clearance on 2001-10-12 under 510(k) number K011373. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTRUMENT DAMPING PORT?

INSTRUMENT DAMPING PORT is a medical device that received FDA 510(k) clearance on 2001-10-12. The listed applicant is Medcanica, Inc.. The 510(k) number is K011373.

When did INSTRUMENT DAMPING PORT receive FDA 510(k) clearance?

INSTRUMENT DAMPING PORT received FDA 510(k) clearance on 2001-10-12, under 510(k) number K011373.

Who is the listed applicant for INSTRUMENT DAMPING PORT?

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

What is the FDA product code for INSTRUMENT DAMPING PORT?

The FDA product code for INSTRUMENT DAMPING PORT is DRC.

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 Medcanica, 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.

K011349INTERCOSTAL LOCKABLE-DIRECTABLE PORTK994232PHALANGEAL FIXATION SYSTEMK991486ULTRA-CBXK991064METACARPAL FIXATION SYSTEM

Related Devices (Code: DRC)

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.

K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)Synaptic Medical CorporationK241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLCK221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLCK212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLCK172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, 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.

↑