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FDA 510(k)

DISPOSABLE HOLDER FOR HANCOCK MITRAL

K-Number: K811235 · 1981-05-13

ApplicantVascor, Inc.
Decision Date1981-05-13
Product CodeDTJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE HOLDER FOR HANCOCK MITRAL is the device name listed in this FDA 510(k) record. The listed applicant is Vascor, Inc.. It received FDA 510(k) clearance on 1981-05-13 under 510(k) number K811235. The device is classified under product code DTJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE HOLDER FOR HANCOCK MITRAL?

DISPOSABLE HOLDER FOR HANCOCK MITRAL is a medical device that received FDA 510(k) clearance on 1981-05-13. The listed applicant is Vascor, Inc.. The 510(k) number is K811235.

When did DISPOSABLE HOLDER FOR HANCOCK MITRAL receive FDA 510(k) clearance?

DISPOSABLE HOLDER FOR HANCOCK MITRAL received FDA 510(k) clearance on 1981-05-13, under 510(k) number K811235.

Who is the listed applicant for DISPOSABLE HOLDER FOR HANCOCK MITRAL?

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

What is the FDA product code for DISPOSABLE HOLDER FOR HANCOCK MITRAL?

The FDA product code for DISPOSABLE HOLDER FOR HANCOCK MITRAL is DTJ.

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 Vascor, 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.

K811236DISPOSABLE HOLDER FOR HANCOCK AORTIC

Related Devices (Code: DTJ)

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.

K962154CARBOMEDICS HANDLECarbomedics, Inc.K960169CARBOMEDICS VALVE TESTERCarbomedics, Inc.K944214BAXTER HANDLE MODEL 1150Baxter EdwardsK942736CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLECarbomedics, Inc.K880052EDWARDS-DUROMEDICS MITRAL VALVE ROTATORBaxter Healthcare CorpK871596IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)Shiley, 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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