FDA 510(k)

NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER

K-Number: K953597 · 1995-10-07

ApplicantMeadox Medicals, Div. Boston Scientific Corp.

Decision Date1995-10-07

Product CodeEZN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER 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 1995-10-07 under 510(k) number K953597. 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 NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER?

NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER is a medical device that received FDA 510(k) clearance on 1995-10-07. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. The 510(k) number is K953597.

When did NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER receive FDA 510(k) clearance?

NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER received FDA 510(k) clearance on 1995-10-07, under 510(k) number K953597.

Who is the listed applicant for NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER?

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 NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER?

The FDA product code for NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER is EZN.

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

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Related Devices (Code: EZN)

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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.