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FDA 510(k)

OCCLUSION BALLOON CATHETER, MODEL VENOS

K-Number: K081052 · 2008-06-18

ApplicantOscor, Inc.
Decision Date2008-06-18
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OCCLUSION BALLOON CATHETER, MODEL VENOS is the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 2008-06-18 under 510(k) number K081052. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCCLUSION BALLOON CATHETER, MODEL VENOS?

OCCLUSION BALLOON CATHETER, MODEL VENOS is a medical device that received FDA 510(k) clearance on 2008-06-18. The listed applicant is Oscor, Inc.. The 510(k) number is K081052.

When did OCCLUSION BALLOON CATHETER, MODEL VENOS receive FDA 510(k) clearance?

OCCLUSION BALLOON CATHETER, MODEL VENOS received FDA 510(k) clearance on 2008-06-18, under 510(k) number K081052.

Who is the listed applicant for OCCLUSION BALLOON CATHETER, MODEL VENOS?

The FDA 510(k) record lists Oscor, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCCLUSION BALLOON CATHETER, MODEL VENOS?

The FDA product code for OCCLUSION BALLOON CATHETER, MODEL VENOS is DYG.

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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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