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FDA 510(k)

MODIFICATION TO GELBFISH VASCULAR DILATORS

K-Number: K023507 · 2002-11-08

ApplicantVascumetrix, LLC
Decision Date2002-11-08
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO GELBFISH VASCULAR DILATORS is the device name listed in this FDA 510(k) record. The listed applicant is Vascumetrix, LLC. It received FDA 510(k) clearance on 2002-11-08 under 510(k) number K023507. 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 MODIFICATION TO GELBFISH VASCULAR DILATORS?

MODIFICATION TO GELBFISH VASCULAR DILATORS is a medical device that received FDA 510(k) clearance on 2002-11-08. The listed applicant is Vascumetrix, LLC. The 510(k) number is K023507.

When did MODIFICATION TO GELBFISH VASCULAR DILATORS receive FDA 510(k) clearance?

MODIFICATION TO GELBFISH VASCULAR DILATORS received FDA 510(k) clearance on 2002-11-08, under 510(k) number K023507.

Who is the listed applicant for MODIFICATION TO GELBFISH VASCULAR DILATORS?

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

What is the FDA product code for MODIFICATION TO GELBFISH VASCULAR DILATORS?

The FDA product code for MODIFICATION TO GELBFISH VASCULAR DILATORS 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 Vascumetrix, LLC 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.

K030260GELBFISH FLEX VASCULAR DILATORK012256GELBISH VASCULAR DILATOR

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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