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FDA 510(k)

MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS

K-Number: K864155 · 1986-11-20

ApplicantAmerican Edwards Laboratories
Decision Date1986-11-20
Product CodeDTJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1986-11-20 under 510(k) number K864155. 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 MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS?

MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS is a medical device that received FDA 510(k) clearance on 1986-11-20. The listed applicant is American Edwards Laboratories. The 510(k) number is K864155.

When did MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS receive FDA 510(k) clearance?

MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS received FDA 510(k) clearance on 1986-11-20, under 510(k) number K864155.

Who is the listed applicant for MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS?

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

What is the FDA product code for MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS?

The FDA product code for MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS is DTJ.

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Other records listing American 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.

K873485EDSLAB (R) OCCLUSION BALLOON CATHETERK872596TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30K872529THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2K870444HOMEPRO II VOLUMETRIC INFUSION PUMPK864997MEDTRAC VP VOLUMETRIC INFUSION PUMPK864330SHEAR FORCE GAUGE

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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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