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FDA 510(k)

PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE

K-Number: K901531 · 1990-06-20

ApplicantPioneering Technologies, Inc.
Decision Date1990-06-20
Product CodeDNP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE 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 1990-06-20 under 510(k) number K901531. The device is classified under product code DNP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE?

PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE is a medical device that received FDA 510(k) clearance on 1990-06-20. The listed applicant is Pioneering Technologies, Inc.. The 510(k) number is K901531.

When did PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE receive FDA 510(k) clearance?

PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE received FDA 510(k) clearance on 1990-06-20, under 510(k) number K901531.

Who is the listed applicant for PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE?

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-ARTR REUSABLE CORONARY ARTERY PROBE?

The FDA product code for PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE is DNP.

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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 GRAFTK901682PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS

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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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