Piv System

FDA 510(k) K981032 · Medical Solutions, Inc.

Substantially Equivalent

510(k) numberK981032

Submission

Device name
Piv System
Applicant
Medical Solutions, Inc.
Crofton, MD, US
Received
March 19, 1998
Decision date
September 2, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

No product code recorded.

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Questions and answers

When was Piv System cleared by the FDA?

Piv System (K981032) received a 510(k) decision of Substantially Equivalent on September 2, 1998, 167 days after the submission was received.