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FDA 510(k)

COAXIAL DILATOR SET

K-Number: K000737 · 2000-08-01

ApplicantXentek Medical, Inc.
Decision Date2000-08-01
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COAXIAL DILATOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Xentek Medical, Inc.. It received FDA 510(k) clearance on 2000-08-01 under 510(k) number K000737. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAXIAL DILATOR SET?

COAXIAL DILATOR SET is a medical device that received FDA 510(k) clearance on 2000-08-01. The listed applicant is Xentek Medical, Inc.. The 510(k) number is K000737.

When did COAXIAL DILATOR SET receive FDA 510(k) clearance?

COAXIAL DILATOR SET received FDA 510(k) clearance on 2000-08-01, under 510(k) number K000737.

Who is the listed applicant for COAXIAL DILATOR SET?

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

What is the FDA product code for COAXIAL DILATOR SET?

The FDA product code for COAXIAL DILATOR SET is DRE.

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 Xentek Medical, 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.

K000313TEARAWAY INTRODUCER SHEATH

Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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