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)

EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA

K-Number: K980631 · 1999-02-02

ApplicantEmbol-X, Inc.
Decision Date1999-02-02
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Embol-X, Inc.. It received FDA 510(k) clearance on 1999-02-02 under 510(k) number K980631. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA?

EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA is a medical device that received FDA 510(k) clearance on 1999-02-02. The listed applicant is Embol-X, Inc.. The 510(k) number is K980631.

When did EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA receive FDA 510(k) clearance?

EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA received FDA 510(k) clearance on 1999-02-02, under 510(k) number K980631.

Who is the listed applicant for EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA?

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

What is the FDA product code for EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA?

The FDA product code for EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA is DXC.

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 Embol-X, 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.

K022071EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000K020693AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101K002973EMBOL-X INTRODUCER, MODEL CF00200

Related Devices (Code: DXC)

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.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

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.

↑