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FDA 510(k)

EVT EXPANDABLE SHEATH

K-Number: K970470 · 1997-07-31

ApplicantGuidant Cardiac and Vascular Surgery
Decision Date1997-07-31
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EVT EXPANDABLE SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Cardiac and Vascular Surgery. It received FDA 510(k) clearance on 1997-07-31 under 510(k) number K970470. 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 EVT EXPANDABLE SHEATH?

EVT EXPANDABLE SHEATH is a medical device that received FDA 510(k) clearance on 1997-07-31. The listed applicant is Guidant Cardiac and Vascular Surgery. The 510(k) number is K970470.

When did EVT EXPANDABLE SHEATH receive FDA 510(k) clearance?

EVT EXPANDABLE SHEATH received FDA 510(k) clearance on 1997-07-31, under 510(k) number K970470.

Who is the listed applicant for EVT EXPANDABLE SHEATH?

The FDA 510(k) record lists Guidant Cardiac and Vascular Surgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVT EXPANDABLE SHEATH?

The FDA product code for EVT EXPANDABLE SHEATH is DRE.

Related Clinical Trials

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Other records listing Guidant Cardiac and Vascular Surgery 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.

K003889ANCURE SHEATH MODEL # 40315, 40320, 40325K001694GUIDANT RETRIEVER DEVICEK003495ANCURE LLIAC BALLOON CATHETERK002676ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCERK970469EVT ANGIOSCALE ANGIOGRAPHIC CATHETERK970608EVT MARKER BOARD

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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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