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)

ABIOMED BODY LEAD ANALYZER MODEL 200/20

K-Number: K900574 · 1990-03-15

ApplicantAbiomed, Inc.
Decision Date1990-03-15
Product CodeJAO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ABIOMED BODY LEAD ANALYZER MODEL 200/20 is the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 1990-03-15 under 510(k) number K900574. The device is classified under product code JAO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABIOMED BODY LEAD ANALYZER MODEL 200/20?

ABIOMED BODY LEAD ANALYZER MODEL 200/20 is a medical device that received FDA 510(k) clearance on 1990-03-15. The listed applicant is Abiomed, Inc.. The 510(k) number is K900574.

When did ABIOMED BODY LEAD ANALYZER MODEL 200/20 receive FDA 510(k) clearance?

ABIOMED BODY LEAD ANALYZER MODEL 200/20 received FDA 510(k) clearance on 1990-03-15, under 510(k) number K900574.

Who is the listed applicant for ABIOMED BODY LEAD ANALYZER MODEL 200/20?

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

What is the FDA product code for ABIOMED BODY LEAD ANALYZER MODEL 200/20?

The FDA product code for ABIOMED BODY LEAD ANALYZER MODEL 200/20 is JAO.

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 Abiomed, 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.

K25276614Fr Low Profile Introducer KitK241708Abiomed 14Fr Low Profile Introducer KitK221294preCARDIA Occlusion SystemK223161OXY-1 SystemK222113Abiomed 14Fr Low Profile Introducer SetK202330Impella XR Sheath Set

View all 19 devices →

Related Devices (Code: JAO)

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.

K911749L-LINEX-RAY FLUORESCENCEMontifore Medical Center

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.

↑