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FDA 510(k)

DEEPVESSEL FFR

K-Number: K213657 · 2022-04-01

ApplicantKeyamed Na, Inc.
Decision Date2022-04-01
Product CodePJA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DEEPVESSEL FFR is a medical device manufactured by Keyamed Na, Inc.. It received FDA 510(k) clearance on 2022-04-01 under approval number K213657. The device is classified under product code PJA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEEPVESSEL FFR?

DEEPVESSEL FFR is a medical device that received FDA 510(k) clearance on 2022-04-01. It is manufactured by Keyamed Na, Inc.. The 510(k) number is K213657.

When was DEEPVESSEL FFR approved by the FDA?

DEEPVESSEL FFR received FDA 510(k) clearance on 2022-04-01, under approval number K213657.

What company makes DEEPVESSEL FFR?

DEEPVESSEL FFR is manufactured by Keyamed Na, Inc..

What is the FDA product code for DEEPVESSEL FFR?

The FDA product code for DEEPVESSEL FFR is PJA.

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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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