FDA 510(k)

PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT

K-Number: K021984 · 2002-07-02

ApplicantInceptio Medical Technologies, LC

Decision Date2002-07-02

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Inceptio Medical Technologies, LC. It received FDA 510(k) clearance on 2002-07-02 under 510(k) number K021984. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT?

PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT is a medical device that received FDA 510(k) clearance on 2002-07-02. The listed applicant is Inceptio Medical Technologies, LC. The 510(k) number is K021984.

When did PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT receive FDA 510(k) clearance?

PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT received FDA 510(k) clearance on 2002-07-02, under 510(k) number K021984.

Who is the listed applicant for PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT?

The FDA 510(k) record lists Inceptio Medical Technologies, LC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT?

The FDA product code for PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT is IYN.

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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.