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FDA 510(k)

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set

K-Number: K162181 · 2017-01-06

ApplicantCardiacassist, Inc.
Decision Date2017-01-06
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2017-01-06 under 510(k) number K162181. 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 Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set?

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K162181.

When did Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set receive FDA 510(k) clearance?

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set received FDA 510(k) clearance on 2017-01-06, under 510(k) number K162181.

Who is the listed applicant for Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set?

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

What is the FDA product code for Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set?

The FDA product code for Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set is DRE.

Other records listing Cardiacassist, Inc. as applicant

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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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