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FDA 510(k)

EMBOL-X INTRODUCER, MODEL CF00200

K-Number: K002973 · 2001-04-26

ApplicantEmbol-X, Inc.
Decision Date2001-04-26
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOL-X INTRODUCER, MODEL CF00200 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 2001-04-26 under 510(k) number K002973. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMBOL-X INTRODUCER, MODEL CF00200?

EMBOL-X INTRODUCER, MODEL CF00200 is a medical device that received FDA 510(k) clearance on 2001-04-26. The listed applicant is Embol-X, Inc.. The 510(k) number is K002973.

When did EMBOL-X INTRODUCER, MODEL CF00200 receive FDA 510(k) clearance?

EMBOL-X INTRODUCER, MODEL CF00200 received FDA 510(k) clearance on 2001-04-26, under 510(k) number K002973.

Who is the listed applicant for EMBOL-X INTRODUCER, MODEL CF00200?

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 INTRODUCER, MODEL CF00200?

The FDA product code for EMBOL-X INTRODUCER, MODEL CF00200 is DYB.

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.

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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 #CF00101K980631EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, 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.

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