Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR

K-Number: K880052 · 1988-04-01

ApplicantBaxter Healthcare Corp
Decision Date1988-04-01
Product CodeDTJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1988-04-01 under 510(k) number K880052. 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 EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR?

EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR is a medical device that received FDA 510(k) clearance on 1988-04-01. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K880052.

When did EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR receive FDA 510(k) clearance?

EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR received FDA 510(k) clearance on 1988-04-01, under 510(k) number K880052.

Who is the listed applicant for EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR?

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

What is the FDA product code for EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR?

The FDA product code for EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Baxter Healthcare Corp 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.

K190910PrisMax System Version 2K163530PrisMax Control UnitK132734NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETSK130245LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFOK123874INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL SK123868INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET

View all 504 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.K871596IONESCU-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.

↑