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)

MICROSHEATH XL CATHETERS

K-Number: K073289 · 2008-01-11

ApplicantFlowcardia, Inc.
Decision Date2008-01-11
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MICROSHEATH XL CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Flowcardia, Inc.. It received FDA 510(k) clearance on 2008-01-11 under 510(k) number K073289. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSHEATH XL CATHETERS?

MICROSHEATH XL CATHETERS is a medical device that received FDA 510(k) clearance on 2008-01-11. The listed applicant is Flowcardia, Inc.. The 510(k) number is K073289.

When did MICROSHEATH XL CATHETERS receive FDA 510(k) clearance?

MICROSHEATH XL CATHETERS received FDA 510(k) clearance on 2008-01-11, under 510(k) number K073289.

Who is the listed applicant for MICROSHEATH XL CATHETERS?

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

What is the FDA product code for MICROSHEATH XL CATHETERS?

The FDA product code for MICROSHEATH XL CATHETERS is DQY.

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 Flowcardia, 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.

K092175THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200K090621FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100K091254THE CROSSER 14 OTW CATHETER, MODEL CRU014K091119MODIFICATION TO THE CROSSER SYSTEMK080849MICROSHEATH LP AND LP-ATK080765CROSSER LP SYSTEM

View all 11 devices →

Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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.

↑