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FDA 510(k)

BAXTER HANDLE MODEL 1150

K-Number: K944214 · 1995-02-10

ApplicantBaxter Edwards
Decision Date1995-02-10
Product CodeDTJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BAXTER HANDLE MODEL 1150 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Edwards. It received FDA 510(k) clearance on 1995-02-10 under 510(k) number K944214. 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 BAXTER HANDLE MODEL 1150?

BAXTER HANDLE MODEL 1150 is a medical device that received FDA 510(k) clearance on 1995-02-10. The listed applicant is Baxter Edwards. The 510(k) number is K944214.

When did BAXTER HANDLE MODEL 1150 receive FDA 510(k) clearance?

BAXTER HANDLE MODEL 1150 received FDA 510(k) clearance on 1995-02-10, under 510(k) number K944214.

Who is the listed applicant for BAXTER HANDLE MODEL 1150?

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

What is the FDA product code for BAXTER HANDLE MODEL 1150?

The FDA product code for BAXTER HANDLE MODEL 1150 is DTJ.

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Other records listing Baxter Edwards 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.

K993816BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FDK981909BAXTER HEMOSTASIS VALVE INTRODUCERSK980487CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSMK965137FOGARTY VALVULOTOME MODEL 700091K964021INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)K955839MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER

View all 11 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.K942736CARBOMEDICS(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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