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FDA 510(k)

EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000

K-Number: K022071 · 2003-02-14

ApplicantEmbol-X, Inc.
Decision Date2003-02-14
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 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 2003-02-14 under 510(k) number K022071. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000?

EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 is a medical device that received FDA 510(k) clearance on 2003-02-14. The listed applicant is Embol-X, Inc.. The 510(k) number is K022071.

When did EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 receive FDA 510(k) clearance?

EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 received FDA 510(k) clearance on 2003-02-14, under 510(k) number K022071.

Who is the listed applicant for EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000?

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 FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000?

The FDA product code for EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 is DTM.

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.

K020693AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101K002973EMBOL-X INTRODUCER, MODEL CF00200K980631EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA

Related Devices (Code: DTM)

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.

K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronicK242953KIDS Arterial FiltersSorin Group Italia S.R.L.K242092MICRO Arterial FiltersSorin Group Italia S.R.L.K231362OCS Heart Leukocyte Depleting FilterTransMedics, Inc.K123351AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACEMedtronic Perfusion SystemsK122760AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACEMedtronic, Inc.

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.

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