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FDA 510(k)

CARBOMEDICS VALVE TESTER

K-Number: K960169 · 1996-04-15

ApplicantCarbomedics, Inc.
Decision Date1996-04-15
Product CodeDTJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARBOMEDICS VALVE TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Carbomedics, Inc.. It received FDA 510(k) clearance on 1996-04-15 under 510(k) number K960169. 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 CARBOMEDICS VALVE TESTER?

CARBOMEDICS VALVE TESTER is a medical device that received FDA 510(k) clearance on 1996-04-15. The listed applicant is Carbomedics, Inc.. The 510(k) number is K960169.

When did CARBOMEDICS VALVE TESTER receive FDA 510(k) clearance?

CARBOMEDICS VALVE TESTER received FDA 510(k) clearance on 1996-04-15, under 510(k) number K960169.

Who is the listed applicant for CARBOMEDICS VALVE TESTER?

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

What is the FDA product code for CARBOMEDICS VALVE TESTER?

The FDA product code for CARBOMEDICS VALVE TESTER is DTJ.

Related Clinical Trials

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Other records listing Carbomedics, 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.

K970375ANNULOFLO SYSTEMK964665VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)K962154CARBOMEDICS HANDLEK960923CARBOMEDICS MITRAL ROTATORK960706VASCUTEK VASCUSOFT PLUS VASCULAR GRAFTK955588VASCUTEK GRAFT SIZER SET

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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.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.K864155MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESISAmerican Edwards Laboratories

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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