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FDA 510(k)

PARODI CATHETER FOR ANGIOGRAPHY (PARCA)

K-Number: K001917 · 2001-06-06

ApplicantArteria Medical Science, Inc.
Decision Date2001-06-06
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PARODI CATHETER FOR ANGIOGRAPHY (PARCA) is the device name listed in this FDA 510(k) record. The listed applicant is Arteria Medical Science, Inc.. It received FDA 510(k) clearance on 2001-06-06 under 510(k) number K001917. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARODI CATHETER FOR ANGIOGRAPHY (PARCA)?

PARODI CATHETER FOR ANGIOGRAPHY (PARCA) is a medical device that received FDA 510(k) clearance on 2001-06-06. The listed applicant is Arteria Medical Science, Inc.. The 510(k) number is K001917.

When did PARODI CATHETER FOR ANGIOGRAPHY (PARCA) receive FDA 510(k) clearance?

PARODI CATHETER FOR ANGIOGRAPHY (PARCA) received FDA 510(k) clearance on 2001-06-06, under 510(k) number K001917.

Who is the listed applicant for PARODI CATHETER FOR ANGIOGRAPHY (PARCA)?

The FDA 510(k) record lists Arteria Medical Science, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARODI CATHETER FOR ANGIOGRAPHY (PARCA)?

The FDA product code for PARODI CATHETER FOR ANGIOGRAPHY (PARCA) is MJN.

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 Arteria Medical Science, Inc. as applicant

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.

K021210ARTERIA OCCLUSION BALLOONK021293ARTERIA BLOOD FILTER

Related Devices (Code: MJN)

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

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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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