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FDA 510(k)

PORTAGE System

K-Number: K161878 · 2016-09-26

ApplicantBaylis Medical Company, Inc.
Decision Date2016-09-26
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PORTAGE System is a medical device manufactured by Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2016-09-26 under approval number K161878. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTAGE System?

PORTAGE System is a medical device that received FDA 510(k) clearance on 2016-09-26. It is manufactured by Baylis Medical Company, Inc.. The 510(k) number is K161878.

When was PORTAGE System approved by the FDA?

PORTAGE System received FDA 510(k) clearance on 2016-09-26, under approval number K161878.

What company makes PORTAGE System?

PORTAGE System is manufactured by Baylis Medical Company, Inc..

What is the FDA product code for PORTAGE System?

The FDA product code for PORTAGE System is HRX.

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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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