FDA 510(k)

MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R)

K-Number: K945576 · 1995-01-24

ApplicantMeadox Medicals, Div. Boston Scientific Corp.

Decision Date1995-01-24

Product CodeEZN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R) 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 1995-01-24 under 510(k) number K945576. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R)?

MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R) is a medical device that received FDA 510(k) clearance on 1995-01-24. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. The 510(k) number is K945576.

When did MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R) receive FDA 510(k) clearance?

MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R) received FDA 510(k) clearance on 1995-01-24, under 510(k) number K945576.

Who is the listed applicant for MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R)?

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 SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R)?

The FDA product code for MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R) is EZN.

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Other records listing Meadox Medicals, Div. Boston Scientific Corp. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.