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FDA 510(k)

FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06

K-Number: K810162 · 1981-02-04

ApplicantAmerican Edwards Laboratories
Decision Date1981-02-04
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06 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 1981-02-04 under 510(k) number K810162. 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 SOFTJAW 6MM SPRING CLIP, #614-06?

FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06 is a medical device that received FDA 510(k) clearance on 1981-02-04. The listed applicant is American Edwards Laboratories. The 510(k) number is K810162.

When did FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06 receive FDA 510(k) clearance?

FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06 received FDA 510(k) clearance on 1981-02-04, under 510(k) number K810162.

Who is the listed applicant for FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06?

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 SOFTJAW 6MM SPRING CLIP, #614-06?

The FDA product code for FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06 is DXC.

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Related Devices (Code: DXC)

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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