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FDA 510(k)

PTI ANNULOPLASTY RING(STERILE)

K-Number: K905175 · 1992-02-14

ApplicantPioneering Technologies, Inc.
Decision Date1992-02-14
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTI ANNULOPLASTY RING(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 1992-02-14 under 510(k) number K905175. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTI ANNULOPLASTY RING(STERILE)?

PTI ANNULOPLASTY RING(STERILE) is a medical device that received FDA 510(k) clearance on 1992-02-14. The listed applicant is Pioneering Technologies, Inc.. The 510(k) number is K905175.

When did PTI ANNULOPLASTY RING(STERILE) receive FDA 510(k) clearance?

PTI ANNULOPLASTY RING(STERILE) received FDA 510(k) clearance on 1992-02-14, under 510(k) number K905175.

Who is the listed applicant for PTI ANNULOPLASTY RING(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 ANNULOPLASTY RING(STERILE)?

The FDA product code for PTI ANNULOPLASTY RING(STERILE) is KRH.

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Other records listing Pioneering Technologies, Inc. as applicant

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Related Devices (Code: KRH)

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.

K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l.K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGCorcym S.r.l.K253232Seguin Annuloplasty RingABBOTT MEDICALK251982Edwards MC3 Tricuspid annuloplasty ring (4900)Edwards Lifesciences, LLCK251688Carpentier-Edwards Physio Annuloplasty Ring (4450)Edwards Lifesciences, LLCK250859TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc.

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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