FDA 510(k)

PERIPHERAL TRANSLUMINAL ARGIOPLASTY

K-Number: K832279 · 1983-11-14

Decision Date1983-11-14

Product Code

DecisionSubstantially Equivalent

Device Summary

PERIPHERAL TRANSLUMINAL ARGIOPLASTY is the device name listed in this FDA 510(k) record. The listed applicant is Sontek Corp.. It received FDA 510(k) clearance on 1983-11-14 under 510(k) number K832279. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIPHERAL TRANSLUMINAL ARGIOPLASTY?

PERIPHERAL TRANSLUMINAL ARGIOPLASTY is a medical device that received FDA 510(k) clearance on 1983-11-14. The listed applicant is Sontek Corp.. The 510(k) number is K832279.

When did PERIPHERAL TRANSLUMINAL ARGIOPLASTY receive FDA 510(k) clearance?

PERIPHERAL TRANSLUMINAL ARGIOPLASTY received FDA 510(k) clearance on 1983-11-14, under 510(k) number K832279.

Who is the listed applicant for PERIPHERAL TRANSLUMINAL ARGIOPLASTY?

The FDA 510(k) record lists Sontek Corp. as the applicant. This does not by itself establish the device manufacturer.

Related Clinical Trials

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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Other records listing Sontek Corp. as applicant

K831562SONTEK INFUSION CATHETER K810508SONTEK ANGIOGRAPHIC CATHETER

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.