FDA 510(k)

LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015

K-Number: K911355 · 1991-04-15

Decision Date1991-04-15

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015 is the device name listed in this FDA 510(k) record. The listed applicant is Strato Medical Corp.. It received FDA 510(k) clearance on 1991-04-15 under 510(k) number K911355. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015?

LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015 is a medical device that received FDA 510(k) clearance on 1991-04-15. The listed applicant is Strato Medical Corp.. The 510(k) number is K911355.

When did LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015 receive FDA 510(k) clearance?

LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015 received FDA 510(k) clearance on 1991-04-15, under 510(k) number K911355.

Who is the listed applicant for LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015?

The FDA 510(k) record lists Strato Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015?

The FDA product code for LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015 is LJT.

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Other records listing Strato Medical Corp. as applicant

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Related Devices (Code: LJT)

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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.