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FDA 510(k)

FOGARTY FLEXIBLE PROBE

K-Number: K812935 · 1981-11-16

ApplicantAmerican Edwards Laboratories
Decision Date1981-11-16
Product CodeDWP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FOGARTY FLEXIBLE PROBE is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K812935. The device is classified under product code DWP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOGARTY FLEXIBLE PROBE?

FOGARTY FLEXIBLE PROBE is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is American Edwards Laboratories. The 510(k) number is K812935.

When did FOGARTY FLEXIBLE PROBE receive FDA 510(k) clearance?

FOGARTY FLEXIBLE PROBE received FDA 510(k) clearance on 1981-11-16, under 510(k) number K812935.

Who is the listed applicant for FOGARTY FLEXIBLE PROBE?

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

What is the FDA product code for FOGARTY FLEXIBLE PROBE?

The FDA product code for FOGARTY FLEXIBLE PROBE is DWP.

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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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