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FDA 510(k)

ENSTYLET MODELS EC0010, EC0020

K-Number: K993376 · 2000-01-05

ApplicantEndocardial Solutions, Inc.
Decision Date2000-01-05
Product CodeDRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENSTYLET MODELS EC0010, EC0020 is the device name listed in this FDA 510(k) record. The listed applicant is Endocardial Solutions, Inc.. It received FDA 510(k) clearance on 2000-01-05 under 510(k) number K993376. The device is classified under product code DRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENSTYLET MODELS EC0010, EC0020?

ENSTYLET MODELS EC0010, EC0020 is a medical device that received FDA 510(k) clearance on 2000-01-05. The listed applicant is Endocardial Solutions, Inc.. The 510(k) number is K993376.

When did ENSTYLET MODELS EC0010, EC0020 receive FDA 510(k) clearance?

ENSTYLET MODELS EC0010, EC0020 received FDA 510(k) clearance on 2000-01-05, under 510(k) number K993376.

Who is the listed applicant for ENSTYLET MODELS EC0010, EC0020?

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

What is the FDA product code for ENSTYLET MODELS EC0010, EC0020?

The FDA product code for ENSTYLET MODELS EC0010, EC0020 is DRB.

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Other records listing Endocardial Solutions, 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.

K042493ENSITE SYSTEM, MODEL EE3000K033211ENSITE SYSTEMK030129MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000K012926MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000K001437ENSITE 3000 SYSTEM, MODEL EE3000K992479ENSITE 3000 SYSTEM

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Related Devices (Code: DRB)

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.

K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.)K191469Biotronik StyletsBiotronik, Inc.K182660GaltTWSGalt Medical Corp.K170298Liberator Beacon Tip Locking StyletCook IncorporatedK090163STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078St Jude MedicalK080924MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151St. Jude Medical, Cardiac Rhythm Management Divisi

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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