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FDA 510(k)

PERIPHERAL DILATATION ANGIOPLASTY-CATH

K-Number: K834429 · 1984-08-10

ApplicantAmerican Edwards Laboratories
Decision Date1984-08-10
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERIPHERAL DILATATION ANGIOPLASTY-CATH 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 1984-08-10 under 510(k) number K834429. 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 PERIPHERAL DILATATION ANGIOPLASTY-CATH?

PERIPHERAL DILATATION ANGIOPLASTY-CATH is a medical device that received FDA 510(k) clearance on 1984-08-10. The listed applicant is American Edwards Laboratories. The 510(k) number is K834429.

When did PERIPHERAL DILATATION ANGIOPLASTY-CATH receive FDA 510(k) clearance?

PERIPHERAL DILATATION ANGIOPLASTY-CATH received FDA 510(k) clearance on 1984-08-10, under 510(k) number K834429.

Who is the listed applicant for PERIPHERAL DILATATION ANGIOPLASTY-CATH?

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 PERIPHERAL DILATATION ANGIOPLASTY-CATH?

The FDA product code for PERIPHERAL DILATATION ANGIOPLASTY-CATH is LIT.

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Other records listing American Edwards Laboratories as applicant

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Related Devices (Code: LIT)

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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