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FDA 510(k)

ORIGIN CARDIAC STABLIZER OCCLUDER

K-Number: K970611 · 1997-08-19

ApplicantOrigin Medsystems, Inc.
Decision Date1997-08-19
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ORIGIN CARDIAC STABLIZER OCCLUDER is the device name listed in this FDA 510(k) record. The listed applicant is Origin Medsystems, Inc.. It received FDA 510(k) clearance on 1997-08-19 under 510(k) number K970611. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORIGIN CARDIAC STABLIZER OCCLUDER?

ORIGIN CARDIAC STABLIZER OCCLUDER is a medical device that received FDA 510(k) clearance on 1997-08-19. The listed applicant is Origin Medsystems, Inc.. The 510(k) number is K970611.

When did ORIGIN CARDIAC STABLIZER OCCLUDER receive FDA 510(k) clearance?

ORIGIN CARDIAC STABLIZER OCCLUDER received FDA 510(k) clearance on 1997-08-19, under 510(k) number K970611.

Who is the listed applicant for ORIGIN CARDIAC STABLIZER OCCLUDER?

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

What is the FDA product code for ORIGIN CARDIAC STABLIZER OCCLUDER?

The FDA product code for ORIGIN CARDIAC STABLIZER OCCLUDER is DXC.

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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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