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FDA 510(k)

PTI STERNAL CLOSURE WIRE SUTURE

K-Number: K910067 · 1991-05-06

ApplicantPioneering Technologies, Inc.
Decision Date1991-05-06
Product CodeGAQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PTI STERNAL CLOSURE WIRE SUTURE 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 1991-05-06 under 510(k) number K910067. The device is classified under product code GAQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTI STERNAL CLOSURE WIRE SUTURE?

PTI STERNAL CLOSURE WIRE SUTURE is a medical device that received FDA 510(k) clearance on 1991-05-06. The listed applicant is Pioneering Technologies, Inc.. The 510(k) number is K910067.

When did PTI STERNAL CLOSURE WIRE SUTURE receive FDA 510(k) clearance?

PTI STERNAL CLOSURE WIRE SUTURE received FDA 510(k) clearance on 1991-05-06, under 510(k) number K910067.

Who is the listed applicant for PTI STERNAL CLOSURE WIRE SUTURE?

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 STERNAL CLOSURE WIRE SUTURE?

The FDA product code for PTI STERNAL CLOSURE WIRE SUTURE is GAQ.

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Other records listing Pioneering Technologies, Inc. as applicant

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K922025ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIFK905175PTI ANNULOPLASTY RING(STERILE)K905068PTI INTRA-ART (TM) PICK-UP WICKSK905067PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFTK901682PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERSK901815MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY

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Related Devices (Code: GAQ)

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.

K203855CoNextions TR Tendon Repair SystemConextions MedicalK193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd.K172146MERISTEELM/s. Meril Endo Surgery Private Limited.K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc.K081060FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5Core Essence Orthopaedics, LLCK082828SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICESuturtek Incorporated

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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