FDA 510(k)

STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM

K-Number: K951872 · 1995-05-18

Decision Date1995-05-18

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Strato/Infusaid, Inc.. It received FDA 510(k) clearance on 1995-05-18 under 510(k) number K951872. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM?

STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM is a medical device that received FDA 510(k) clearance on 1995-05-18. The listed applicant is Strato/Infusaid, Inc.. The 510(k) number is K951872.

When did STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM receive FDA 510(k) clearance?

STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM received FDA 510(k) clearance on 1995-05-18, under 510(k) number K951872.

Who is the listed applicant for STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM?

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

What is the FDA product code for STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM?

The FDA product code for STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM is LJT.

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Other records listing Strato/Infusaid, Inc. as applicant

K960391STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771 K953529STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM K954720STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS K953254STRATO/INFUSAID INFUSE-A-KIT K953256STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE CENTRAL VENOUS CATHETER SYSTEMS K953436STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER SYSTESM

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Related Devices (Code: LJT)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.