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FDA 510(k)

IMPCO DISPOSABLE AORTIC PUNCH

K-Number: K780247 · 1978-02-27

ApplicantThoratec Laboratories Corp.
Decision Date1978-02-27
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPCO DISPOSABLE AORTIC PUNCH is the device name listed in this FDA 510(k) record. The listed applicant is Thoratec Laboratories Corp.. It received FDA 510(k) clearance on 1978-02-27 under 510(k) number K780247. 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 IMPCO DISPOSABLE AORTIC PUNCH?

IMPCO DISPOSABLE AORTIC PUNCH is a medical device that received FDA 510(k) clearance on 1978-02-27. The listed applicant is Thoratec Laboratories Corp.. The 510(k) number is K780247.

When did IMPCO DISPOSABLE AORTIC PUNCH receive FDA 510(k) clearance?

IMPCO DISPOSABLE AORTIC PUNCH received FDA 510(k) clearance on 1978-02-27, under 510(k) number K780247.

Who is the listed applicant for IMPCO DISPOSABLE AORTIC PUNCH?

The FDA 510(k) record lists Thoratec Laboratories Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPCO DISPOSABLE AORTIC PUNCH?

The FDA product code for IMPCO DISPOSABLE AORTIC PUNCH is DWS.

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Related Devices (Code: DWS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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