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FDA 510(k)

CARBOMEDICS HANDLE

K-Number: K962154 · 1996-08-27

ApplicantCarbomedics, Inc.
Decision Date1996-08-27
Product CodeDTJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARBOMEDICS HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Carbomedics, Inc.. It received FDA 510(k) clearance on 1996-08-27 under 510(k) number K962154. 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 HANDLE?

CARBOMEDICS HANDLE is a medical device that received FDA 510(k) clearance on 1996-08-27. The listed applicant is Carbomedics, Inc.. The 510(k) number is K962154.

When did CARBOMEDICS HANDLE receive FDA 510(k) clearance?

CARBOMEDICS HANDLE received FDA 510(k) clearance on 1996-08-27, under 510(k) number K962154.

Who is the listed applicant for CARBOMEDICS HANDLE?

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 HANDLE?

The FDA product code for CARBOMEDICS HANDLE 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 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)K960923CARBOMEDICS MITRAL ROTATORK960706VASCUTEK VASCUSOFT PLUS VASCULAR GRAFTK960169CARBOMEDICS VALVE TESTERK955588VASCUTEK 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.

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.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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