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)

CAPIOX BUBBLE TRAP WITH X-COATING

K-Number: K090698 · 2009-06-08

ApplicantTerumo Cardiovascular Systems
Decision Date2009-06-08
Product CodeKRL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAPIOX BUBBLE TRAP WITH X-COATING is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems. It received FDA 510(k) clearance on 2009-06-08 under 510(k) number K090698. The device is classified under product code KRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPIOX BUBBLE TRAP WITH X-COATING?

CAPIOX BUBBLE TRAP WITH X-COATING is a medical device that received FDA 510(k) clearance on 2009-06-08. The listed applicant is Terumo Cardiovascular Systems. The 510(k) number is K090698.

When did CAPIOX BUBBLE TRAP WITH X-COATING receive FDA 510(k) clearance?

CAPIOX BUBBLE TRAP WITH X-COATING received FDA 510(k) clearance on 2009-06-08, under 510(k) number K090698.

Who is the listed applicant for CAPIOX BUBBLE TRAP WITH X-COATING?

The FDA 510(k) record lists Terumo Cardiovascular Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPIOX BUBBLE TRAP WITH X-COATING?

The FDA product code for CAPIOX BUBBLE TRAP WITH X-COATING is KRL.

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 Terumo Cardiovascular Systems 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.

K112229SARN CENTRIFUGAL PUMP

Related Devices (Code: KRL)

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.

K103469STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05Sorin Group Deutschland GmbHK071231EDAC QUANTIFIERLuna Innovations, Inc.K961364AUTOMATIC TUBING CLAMP SYSTEM (ATC)Rocky Mountain Research, Inc.K961598ELS AUTOMATIC TUBING CLAMP SYSTEMRocky Mountain Research, Inc.K940651SARNS ULTRASONIC AIR SENSOR3M Health Care, SarnsK935977SARNS AIR DETECTION SYSTEM3M Health Care, Sarns

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.

↑