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FDA 510(k)

FOGARTY BALLON ANGIOPLASTY CATHETERS

K-Number: K803057 · 1981-01-13

ApplicantAmerican Edwards Laboratories
Decision Date1981-01-13
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FOGARTY BALLON ANGIOPLASTY CATHETERS 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 1981-01-13 under 510(k) number K803057. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOGARTY BALLON ANGIOPLASTY CATHETERS?

FOGARTY BALLON ANGIOPLASTY CATHETERS is a medical device that received FDA 510(k) clearance on 1981-01-13. The listed applicant is American Edwards Laboratories. The 510(k) number is K803057.

When did FOGARTY BALLON ANGIOPLASTY CATHETERS receive FDA 510(k) clearance?

FOGARTY BALLON ANGIOPLASTY CATHETERS received FDA 510(k) clearance on 1981-01-13, under 510(k) number K803057.

Who is the listed applicant for FOGARTY BALLON ANGIOPLASTY CATHETERS?

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 BALLON ANGIOPLASTY CATHETERS?

The FDA product code for FOGARTY BALLON ANGIOPLASTY CATHETERS is LIT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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