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FDA 510(k)

FOGARTY 6MM SOFTJAW CLIP

K-Number: K832554 · 1983-09-29

ApplicantAmerican Edwards Laboratories
Decision Date1983-09-29
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FOGARTY 6MM SOFTJAW CLIP 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 1983-09-29 under 510(k) number K832554. 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 FOGARTY 6MM SOFTJAW CLIP?

FOGARTY 6MM SOFTJAW CLIP is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is American Edwards Laboratories. The 510(k) number is K832554.

When did FOGARTY 6MM SOFTJAW CLIP receive FDA 510(k) clearance?

FOGARTY 6MM SOFTJAW CLIP received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832554.

Who is the listed applicant for FOGARTY 6MM SOFTJAW CLIP?

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 6MM SOFTJAW CLIP?

The FDA product code for FOGARTY 6MM SOFTJAW CLIP 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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