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FDA 510(k)

GELBISH VASCULAR DILATOR

K-Number: K012256 · 2001-12-20

ApplicantVascumetrix, LLC
Decision Date2001-12-20
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GELBISH VASCULAR DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Vascumetrix, LLC. It received FDA 510(k) clearance on 2001-12-20 under 510(k) number K012256. 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 GELBISH VASCULAR DILATOR?

GELBISH VASCULAR DILATOR is a medical device that received FDA 510(k) clearance on 2001-12-20. The listed applicant is Vascumetrix, LLC. The 510(k) number is K012256.

When did GELBISH VASCULAR DILATOR receive FDA 510(k) clearance?

GELBISH VASCULAR DILATOR received FDA 510(k) clearance on 2001-12-20, under 510(k) number K012256.

Who is the listed applicant for GELBISH VASCULAR DILATOR?

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 GELBISH VASCULAR DILATOR?

The FDA product code for GELBISH VASCULAR DILATOR 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 DILATORK023507MODIFICATION TO GELBFISH VASCULAR DILATORS

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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