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FDA 510(k)

ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM

K-Number: K864374 · 1987-03-16

ApplicantSherwood Medical Co.
Decision Date1987-03-16
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sherwood Medical Co.. It received FDA 510(k) clearance on 1987-03-16 under 510(k) number K864374. 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 ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM?

ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1987-03-16. The listed applicant is Sherwood Medical Co.. The 510(k) number is K864374.

When did ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM receive FDA 510(k) clearance?

ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM received FDA 510(k) clearance on 1987-03-16, under 510(k) number K864374.

Who is the listed applicant for ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM?

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

What is the FDA product code for ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM?

The FDA product code for ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM is CAC.

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Other records listing Sherwood Medical Co. 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.

K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONSK960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAK962880SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEMK960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMK960677KANGAROO JEJUNAL FEEDING SYSTEMK960632KANGAROO FEEDING TUBE PLACMENT STYLET

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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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