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)

BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900

K-Number: K892443 · 1989-11-08

ApplicantGish Biomedical, Inc.
Decision Date1989-11-08
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900 is the device name listed in this FDA 510(k) record. The listed applicant is Gish Biomedical, Inc.. It received FDA 510(k) clearance on 1989-11-08 under 510(k) number K892443. 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 BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900?

BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900 is a medical device that received FDA 510(k) clearance on 1989-11-08. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K892443.

When did BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900 receive FDA 510(k) clearance?

BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900 received FDA 510(k) clearance on 1989-11-08, under 510(k) number K892443.

Who is the listed applicant for BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900?

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

What is the FDA product code for BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900?

The FDA product code for BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900 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 Gish Biomedical, 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.

K090449MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LTK090450MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LTK091062MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730K083131MEDOS HILITE RESERVOIR, MODEL: 4030K082403MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LTK082082GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING

View all 75 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.

↑