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FDA 510(k)

INTEGRAL DISPOSABLE HOLDER CARPENTIER

K-Number: K792034 · 1979-12-07

ApplicantEdwards Laboratories
Decision Date1979-12-07
Product CodeDTJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTEGRAL DISPOSABLE HOLDER CARPENTIER is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Laboratories. It received FDA 510(k) clearance on 1979-12-07 under 510(k) number K792034. 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 INTEGRAL DISPOSABLE HOLDER CARPENTIER?

INTEGRAL DISPOSABLE HOLDER CARPENTIER is a medical device that received FDA 510(k) clearance on 1979-12-07. The listed applicant is Edwards Laboratories. The 510(k) number is K792034.

When did INTEGRAL DISPOSABLE HOLDER CARPENTIER receive FDA 510(k) clearance?

INTEGRAL DISPOSABLE HOLDER CARPENTIER received FDA 510(k) clearance on 1979-12-07, under 510(k) number K792034.

Who is the listed applicant for INTEGRAL DISPOSABLE HOLDER CARPENTIER?

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 INTEGRAL DISPOSABLE HOLDER CARPENTIER?

The FDA product code for INTEGRAL DISPOSABLE HOLDER CARPENTIER 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. ANNULOPLASTYK790047CARDIAC OUTPUT COMPUTER, MDEL 9520AK790022DISPOSABLE HOLDER FOR BIOPROSTHESISK781535AC 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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