FDA 510(k)

STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED

K-Number: K905845 · 1991-04-19

Decision Date1991-04-19

Product CodeLJT

Advisory CommitteeHO

DecisionUnknown

Device Summary

STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED 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 1991-04-19 under 510(k) number K905845. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED?

STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED is a medical device that received FDA 510(k) clearance on 1991-04-19. The listed applicant is Strato Medical Corp.. The 510(k) number is K905845.

When did STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED receive FDA 510(k) clearance?

STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED received FDA 510(k) clearance on 1991-04-19, under 510(k) number K905845.

Who is the listed applicant for STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED?

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 STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED?

The FDA product code for STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED 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.