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FDA 510(k)

HYBRID PERIPHERAL DILATION CATHETER

K-Number: K834220 · 1984-01-27

ApplicantAmerican Edwards Laboratories
Decision Date1984-01-27
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HYBRID PERIPHERAL DILATION CATHETER 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 1984-01-27 under 510(k) number K834220. 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 HYBRID PERIPHERAL DILATION CATHETER?

HYBRID PERIPHERAL DILATION CATHETER is a medical device that received FDA 510(k) clearance on 1984-01-27. The listed applicant is American Edwards Laboratories. The 510(k) number is K834220.

When did HYBRID PERIPHERAL DILATION CATHETER receive FDA 510(k) clearance?

HYBRID PERIPHERAL DILATION CATHETER received FDA 510(k) clearance on 1984-01-27, under 510(k) number K834220.

Who is the listed applicant for HYBRID PERIPHERAL DILATION CATHETER?

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 HYBRID PERIPHERAL DILATION CATHETER?

The FDA product code for HYBRID PERIPHERAL DILATION CATHETER is LIT.

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Other records listing American Edwards Laboratories as applicant

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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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