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FDA 510(k)

VESSEL DILATOR

K-Number: K904476 · 1990-12-10

ApplicantDatascope Corp.
Decision Date1990-12-10
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VESSEL DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1990-12-10 under 510(k) number K904476. 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 VESSEL DILATOR?

VESSEL DILATOR is a medical device that received FDA 510(k) clearance on 1990-12-10. The listed applicant is Datascope Corp.. The 510(k) number is K904476.

When did VESSEL DILATOR receive FDA 510(k) clearance?

VESSEL DILATOR received FDA 510(k) clearance on 1990-12-10, under 510(k) number K904476.

Who is the listed applicant for VESSEL DILATOR?

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

What is the FDA product code for VESSEL DILATOR?

The FDA product code for VESSEL 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

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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