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FDA 510(k)

PERIPHERAL VASCULAR DILATOR

K-Number: K974617 · 1998-12-01

ApplicantEndovascular Instruments, Inc.
Decision Date1998-12-01
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERIPHERAL VASCULAR DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Endovascular Instruments, Inc.. It received FDA 510(k) clearance on 1998-12-01 under 510(k) number K974617. 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 PERIPHERAL VASCULAR DILATOR?

PERIPHERAL VASCULAR DILATOR is a medical device that received FDA 510(k) clearance on 1998-12-01. The listed applicant is Endovascular Instruments, Inc.. The 510(k) number is K974617.

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

PERIPHERAL VASCULAR DILATOR received FDA 510(k) clearance on 1998-12-01, under 510(k) number K974617.

Who is the listed applicant for PERIPHERAL VASCULAR DILATOR?

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

What is the FDA product code for PERIPHERAL VASCULAR DILATOR?

The FDA product code for PERIPHERAL VASCULAR DILATOR is DRE.

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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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