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FDA 510(k)

PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT

K-Number: K905067 · 1991-03-18

ApplicantPioneering Technologies, Inc.
Decision Date1991-03-18
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT 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 1991-03-18 under 510(k) number K905067. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT?

PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT is a medical device that received FDA 510(k) clearance on 1991-03-18. The listed applicant is Pioneering Technologies, Inc.. The 510(k) number is K905067.

When did PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT receive FDA 510(k) clearance?

PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT received FDA 510(k) clearance on 1991-03-18, under 510(k) number K905067.

Who is the listed applicant for PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT?

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 ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT?

The FDA product code for PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT is DSY.

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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 SUTUREK901682PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERSK901815MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY

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Related Devices (Code: DSY)

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.

K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLCK252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies LimitedK241550Gelweave™ Vascular ProsthesesVascutek, Ltd.K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical CorporationK240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, 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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