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FDA 510(k)

SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM

K-Number: K883058 · 1988-10-28

ApplicantSolco Basle, Inc.
Decision Date1988-10-28
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SOLCOTRANS ORTHO. DRAINAGE/REINFUSION 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 1988-10-28 under 510(k) number K883058. 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 ORTHO. DRAINAGE/REINFUSION SYSTEM?

SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1988-10-28. The listed applicant is Solco Basle, Inc.. The 510(k) number is K883058.

When did SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM receive FDA 510(k) clearance?

SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM received FDA 510(k) clearance on 1988-10-28, under 510(k) number K883058.

Who is the listed applicant for SOLCOTRANS ORTHO. DRAINAGE/REINFUSION 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 ORTHO. DRAINAGE/REINFUSION SYSTEM?

The FDA product code for SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM is CAC.

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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 SYSTEMK896858SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEMK896203SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER

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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.

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