FDA 510(k)

TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000

K-Number: K904491 · 1991-02-01

Decision Date1991-02-01

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 is the device name listed in this FDA 510(k) record. The listed applicant is Lifestream Int'L, Inc.. It received FDA 510(k) clearance on 1991-02-01 under 510(k) number K904491. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000?

TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 is a medical device that received FDA 510(k) clearance on 1991-02-01. The listed applicant is Lifestream Int'L, Inc.. The 510(k) number is K904491.

When did TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 receive FDA 510(k) clearance?

TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 received FDA 510(k) clearance on 1991-02-01, under 510(k) number K904491.

Who is the listed applicant for TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000?

The FDA 510(k) record lists Lifestream Int'L, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000?

The FDA product code for TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 is DQO.

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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.