FDA 510(k)

LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI

K-Number: K905848 · 1991-04-08

Decision Date1991-04-08

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI 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 1991-04-08 under 510(k) number K905848. 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 LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI?

LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI is a medical device that received FDA 510(k) clearance on 1991-04-08. The listed applicant is Strato Medical Corp.. The 510(k) number is K905848.

When did LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI receive FDA 510(k) clearance?

LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI received FDA 510(k) clearance on 1991-04-08, under 510(k) number K905848.

Who is the listed applicant for LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI?

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 LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI?

The FDA product code for LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI is LJT.

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Other records listing Strato Medical Corp. as applicant

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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.