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FDA 510(k)

DISPOSABLE HOLDER FOR BIOPROSTHESIS

K-Number: K790022 · 1979-01-15

ApplicantEdwards Laboratories
Decision Date1979-01-15
Product CodeDTJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE HOLDER FOR BIOPROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Laboratories. It received FDA 510(k) clearance on 1979-01-15 under 510(k) number K790022. 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 BIOPROSTHESIS?

DISPOSABLE HOLDER FOR BIOPROSTHESIS is a medical device that received FDA 510(k) clearance on 1979-01-15. The listed applicant is Edwards Laboratories. The 510(k) number is K790022.

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

DISPOSABLE HOLDER FOR BIOPROSTHESIS received FDA 510(k) clearance on 1979-01-15, under 510(k) number K790022.

Who is the listed applicant for DISPOSABLE HOLDER FOR BIOPROSTHESIS?

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

What is the FDA product code for DISPOSABLE HOLDER FOR BIOPROSTHESIS?

The FDA product code for DISPOSABLE HOLDER FOR BIOPROSTHESIS is DTJ.

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Other records listing Edwards Laboratories 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.

K801552MOD. 9542 FLOW-THRU INJECT. TEMP. SENSORK800655MODEL 100 SPECTRAVIEWK792441CARPENTIER-EDWARDS FLEX. ANNULOPLASTYK792034INTEGRAL DISPOSABLE HOLDER CARPENTIERK790047CARDIAC OUTPUT COMPUTER, MDEL 9520AK781535AC ADAPTER:MODELS 9525,9526,9527

View all 12 devices →

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

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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