FDA 510(k)

ISOFLO(TM) HIGH PRESSURE INJECTION LINES

K-Number: K901382 · 1990-07-19

ApplicantHealthdyne Cardiovascular, Inc.

Decision Date1990-07-19

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ISOFLO(TM) HIGH PRESSURE INJECTION LINES is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne Cardiovascular, Inc.. It received FDA 510(k) clearance on 1990-07-19 under 510(k) number K901382. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOFLO(TM) HIGH PRESSURE INJECTION LINES?

ISOFLO(TM) HIGH PRESSURE INJECTION LINES is a medical device that received FDA 510(k) clearance on 1990-07-19. The listed applicant is Healthdyne Cardiovascular, Inc.. The 510(k) number is K901382.

When did ISOFLO(TM) HIGH PRESSURE INJECTION LINES receive FDA 510(k) clearance?

ISOFLO(TM) HIGH PRESSURE INJECTION LINES received FDA 510(k) clearance on 1990-07-19, under 510(k) number K901382.

Who is the listed applicant for ISOFLO(TM) HIGH PRESSURE INJECTION LINES?

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

What is the FDA product code for ISOFLO(TM) HIGH PRESSURE INJECTION LINES?

The FDA product code for ISOFLO(TM) HIGH PRESSURE INJECTION LINES is DXT.

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Other records listing Healthdyne Cardiovascular, Inc. as applicant

K901643ISOFLO(TM) AMNIOCENTESIS TRAY K901084ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.K900665DRESSING CHANGE KIT K895763ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING

Related Devices (Code: DXT)

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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.