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FDA 510(k)

PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)

K-Number: K891786 · 1989-10-12

ApplicantPioneering Technologies, Inc.
Decision Date1989-10-12
Product CodeDWP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) 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 1989-10-12 under 510(k) number K891786. The device is classified under product code DWP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)?

PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) is a medical device that received FDA 510(k) clearance on 1989-10-12. The listed applicant is Pioneering Technologies, Inc.. The 510(k) number is K891786.

When did PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) receive FDA 510(k) clearance?

PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) received FDA 510(k) clearance on 1989-10-12, under 510(k) number K891786.

Who is the listed applicant for PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)?

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(R) CORONARY ARTERY PROBE (STERILE)?

The FDA product code for PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) is DWP.

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Other records listing Pioneering Technologies, 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.

K922025ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIFK905175PTI ANNULOPLASTY RING(STERILE)K905068PTI INTRA-ART (TM) PICK-UP WICKSK910067PTI STERNAL CLOSURE WIRE SUTUREK905067PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFTK901815MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY

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Related Devices (Code: DWP)

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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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