FDA 510(k)

MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM)

K-Number: K904410 · 1991-03-25

ApplicantMeadox Medicals, Div. Boston Scientific Corp.

Decision Date1991-03-25

Product CodeLIT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. It received FDA 510(k) clearance on 1991-03-25 under 510(k) number K904410. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM)?

MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM) is a medical device that received FDA 510(k) clearance on 1991-03-25. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. The 510(k) number is K904410.

When did MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM) receive FDA 510(k) clearance?

MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM) received FDA 510(k) clearance on 1991-03-25, under 510(k) number K904410.

Who is the listed applicant for MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM)?

The FDA 510(k) record lists Meadox Medicals, Div. Boston Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM)?

The FDA product code for MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM) is LIT.

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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.