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)

BIODYNAMICS AUTOTRANSFUSION RESERVOIR

K-Number: K881631 · 1988-09-09

ApplicantBiodynamics Corp.
Decision Date1988-09-09
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIODYNAMICS AUTOTRANSFUSION RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamics Corp.. It received FDA 510(k) clearance on 1988-09-09 under 510(k) number K881631. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIODYNAMICS AUTOTRANSFUSION RESERVOIR?

BIODYNAMICS AUTOTRANSFUSION RESERVOIR is a medical device that received FDA 510(k) clearance on 1988-09-09. The listed applicant is Biodynamics Corp.. The 510(k) number is K881631.

When did BIODYNAMICS AUTOTRANSFUSION RESERVOIR receive FDA 510(k) clearance?

BIODYNAMICS AUTOTRANSFUSION RESERVOIR received FDA 510(k) clearance on 1988-09-09, under 510(k) number K881631.

Who is the listed applicant for BIODYNAMICS AUTOTRANSFUSION RESERVOIR?

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

What is the FDA product code for BIODYNAMICS AUTOTRANSFUSION RESERVOIR?

The FDA product code for BIODYNAMICS AUTOTRANSFUSION RESERVOIR is CAC.

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 Biodynamics 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.

K051675BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZERK884033BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZERK881968BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZERK874361BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZERK873807AUTOTRANSFUSION APPARATUSK874034ADR-22 AUTOMATIC DIALYZER REPROCESSOR

View all 21 devices →

Related Devices (Code: CAC)

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.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

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.

↑