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FDA 510(k)

V8 TRANSLUMINAL BAV CATHETER

K-Number: K132728 · 2013-11-22

ApplicantIntervalve, Inc.
Decision Date2013-11-22
Product CodeOZT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

V8 TRANSLUMINAL BAV CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Intervalve, Inc.. It received FDA 510(k) clearance on 2013-11-22 under 510(k) number K132728. The device is classified under product code OZT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V8 TRANSLUMINAL BAV CATHETER?

V8 TRANSLUMINAL BAV CATHETER is a medical device that received FDA 510(k) clearance on 2013-11-22. The listed applicant is Intervalve, Inc.. The 510(k) number is K132728.

When did V8 TRANSLUMINAL BAV CATHETER receive FDA 510(k) clearance?

V8 TRANSLUMINAL BAV CATHETER received FDA 510(k) clearance on 2013-11-22, under 510(k) number K132728.

Who is the listed applicant for V8 TRANSLUMINAL BAV CATHETER?

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

What is the FDA product code for V8 TRANSLUMINAL BAV CATHETER?

The FDA product code for V8 TRANSLUMINAL BAV CATHETER is OZT.

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 Intervalve, Inc. 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.

K123111V8 TRANSLUMINAL BAV CATHETER

Related Devices (Code: OZT)

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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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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