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)

SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM

K-Number: K896858 · 1990-04-05

ApplicantSolco Basle, Inc.
Decision Date1990-04-05
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Solco Basle, Inc.. It received FDA 510(k) clearance on 1990-04-05 under 510(k) number K896858. 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 SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM?

SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1990-04-05. The listed applicant is Solco Basle, Inc.. The 510(k) number is K896858.

When did SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM receive FDA 510(k) clearance?

SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM received FDA 510(k) clearance on 1990-04-05, under 510(k) number K896858.

Who is the listed applicant for SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM?

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

What is the FDA product code for SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM?

The FDA product code for SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM 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 Solco Basle, 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.

K913177SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEMK913247SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEMK915867SOLCOVAC WOUND DRAINAGE SYSTEMK896857SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEMK896203SOLCOSEPT(TM) BLOOD TRANSFUSION FILTERK883058SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM

View all 10 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.

↑