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FDA 510(k)

PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)

K-Number: K882879 · 1988-09-12

ApplicantPioneering Technologies, Inc.
Decision Date1988-09-12
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER) is the device name listed in this FDA 510(k) record. The listed applicant is Pioneering Technologies, Inc.. It received FDA 510(k) clearance on 1988-09-12 under 510(k) number K882879. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)?

PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER) is a medical device that received FDA 510(k) clearance on 1988-09-12. The listed applicant is Pioneering Technologies, Inc.. The 510(k) number is K882879.

When did PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER) receive FDA 510(k) clearance?

PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER) received FDA 510(k) clearance on 1988-09-12, under 510(k) number K882879.

Who is the listed applicant for PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)?

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

What is the FDA product code for PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)?

The FDA product code for PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER) is DXC.

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Other records listing Pioneering Technologies, Inc. as applicant

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Related Devices (Code: DXC)

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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