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FDA 510(k)

OLBERT CATHETER SYSTEM

K-Number: K833616 · 1983-12-26

ApplicantMeadox Medicals, Div. Boston Scientific Corp.
Decision Date1983-12-26
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OLBERT CATHETER SYSTEM 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 1983-12-26 under 510(k) number K833616. 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 OLBERT CATHETER SYSTEM?

OLBERT CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 1983-12-26. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. The 510(k) number is K833616.

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

OLBERT CATHETER SYSTEM received FDA 510(k) clearance on 1983-12-26, under 510(k) number K833616.

Who is the listed applicant for OLBERT CATHETER SYSTEM?

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 OLBERT CATHETER SYSTEM?

The FDA product code for OLBERT CATHETER SYSTEM is LIT.

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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.

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