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)

ENDOMYOCARDIAL BIOPSY DEVICE

K-Number: K870186 · 1987-02-20

ApplicantMansfield Scientific, Inc.
Decision Date1987-02-20
Product CodeDWZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENDOMYOCARDIAL BIOPSY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Mansfield Scientific, Inc.. It received FDA 510(k) clearance on 1987-02-20 under 510(k) number K870186. The device is classified under product code DWZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOMYOCARDIAL BIOPSY DEVICE?

ENDOMYOCARDIAL BIOPSY DEVICE is a medical device that received FDA 510(k) clearance on 1987-02-20. The listed applicant is Mansfield Scientific, Inc.. The 510(k) number is K870186.

When did ENDOMYOCARDIAL BIOPSY DEVICE receive FDA 510(k) clearance?

ENDOMYOCARDIAL BIOPSY DEVICE received FDA 510(k) clearance on 1987-02-20, under 510(k) number K870186.

Who is the listed applicant for ENDOMYOCARDIAL BIOPSY DEVICE?

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

What is the FDA product code for ENDOMYOCARDIAL BIOPSY DEVICE?

The FDA product code for ENDOMYOCARDIAL BIOPSY DEVICE is DWZ.

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 Mansfield Scientific, 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.

K865017ANGIOSCOPEK855103CIRIBART GYUDUBG CATGETERK853850EXPLORERK852797HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODEK851848PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETERK844752TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA

View all 8 devices →

Related Devices (Code: DWZ)

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.

K252722Biopsy ForcepsFehling Instruments GmbHK170726Biopsy ForcepsFehling Instruments GmbH & Co. KGK072051NOVATOME, MODEL: SU101-50Scholten Surgical Instruments, Inc.K010473SPARROWHAWK DISPOSABLEAtc Technologies, Inc.K000409MODIFICATION TO T-REX BIOPSY FORCEPSBoston Scientific CorpK991486ULTRA-CBXMedcanica, 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.

↑