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FDA 510(k)

HYCULT DIAMOND CORONARY BYPASS KNIFE

K-Number: K900379 · 1990-03-19

ApplicantSt. Jude Medical, Inc.
Decision Date1990-03-19
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HYCULT DIAMOND CORONARY BYPASS KNIFE is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Inc.. It received FDA 510(k) clearance on 1990-03-19 under 510(k) number K900379. The device is classified under product code DWS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYCULT DIAMOND CORONARY BYPASS KNIFE?

HYCULT DIAMOND CORONARY BYPASS KNIFE is a medical device that received FDA 510(k) clearance on 1990-03-19. The listed applicant is St. Jude Medical, Inc.. The 510(k) number is K900379.

When did HYCULT DIAMOND CORONARY BYPASS KNIFE receive FDA 510(k) clearance?

HYCULT DIAMOND CORONARY BYPASS KNIFE received FDA 510(k) clearance on 1990-03-19, under 510(k) number K900379.

Who is the listed applicant for HYCULT DIAMOND CORONARY BYPASS KNIFE?

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

What is the FDA product code for HYCULT DIAMOND CORONARY BYPASS KNIFE?

The FDA product code for HYCULT DIAMOND CORONARY BYPASS KNIFE is DWS.

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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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